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Medtronic Receives US Approval for InPen App with Missed Meal Dose Detection
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US-Irish firm Medtronic (NYSE: MDT) has announced US market approval for its new InPen app, which features missed meal dose detection. This innovation marks a significant step in the launch of Medtronic’s Smart MDI system, integrated with the Simplera continuous glucose monitor (CGM). InPen App: A Pioneer in Real-Time Insulin…
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New Horizon Health Registers Three Medical Devices in Hong Kong’s Department of Health
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Hangzhou-based New Horizon Health Ltd (HKG: 6606) has announced the successful registration of three of its medical products with the Department of Health in the Hong Kong Special Administrative Region, facilitated through the Medical Device Administrative Control System (MDACS). This development marks a significant expansion of the company’s reach and…
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Beijing Balance Medical Technology’s ePTFE Implant Accepted for NMPA Review
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for an expanded polytetrafluoroethylene (ePTFE) implant. This Category III medical device is specifically processed and manufactured for the repair or reconstruction of the pericardium during cardiac surgery.…
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AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
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US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and…
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Xeltis AG Enrolls First Patient in US Pivotal Trial for aXess with FDA BTD Status
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Holland-based Xeltis AG has announced the enrollment of the first patient in a US-staged pivotal trial for its flagship product, aXess, which has been granted Breakthrough Device Designation (BTD) status by the US FDA. This marks a significant milestone in the development and potential approval of aXess, a novel medical…
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Peijia Medical Achieves First Compassionate Use of Taurus Trio TAVR System in Hong Kong
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Peijia Medical Ltd (HKG: 9996), a leading medical device company, has announced the completion of its first compassionate use case utilizing the Taurus Trio transcatheter aortic valve replacement (TAVR) system in Hong Kong. This milestone marks a significant step in the application of the company’s advanced cardiovascular technology in the…
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J&J MedTech Secures Exclusive Distribution Deal with Responsive Arthroscopy
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Johnson & Johnson (J&J, NYSE: JNJ) MedTech, a leading player in the US medical technology sector, has announced an exclusive commercial distribution agreement with Responsive Arthroscopy Inc., an innovative medical device company specializing in sports soft tissue repair solutions. This strategic partnership is aimed at bolstering J&J MedTech’s sports medicine…
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GE Healthcare’s SIGNA MAGNUS MRI Scanner Receives FDA 510(k) Clearance
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US medical device and life sciences leader GE Healthcare Technologies Inc. (NASDAQ: GEHC) has announced the receipt of FDA 510(k) clearance for its innovative SIGNA MAGNUS, a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner. This clearance marks a significant advancement in medical imaging technology, offering new capabilities for the…
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J&J MedTech Receives FDA IDE for OTTAVA Robotic Surgical System Trials
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US-based Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing its OTTAVA robotic surgical system to commence clinical trials at various sites across the United States. This approval marks a significant step…
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Sino Medical Sciences Technology Secures Marketing Approval in Peru for HT Supreme Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical technology company, has announced that it has received marketing approval in Peru for its HT Supreme drug-eluting stent system. This approval allows the use of the system to improve the diameter of the coronary artery lumen in symptomatic heart…
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Johnson & Johnson MedTech’s Varipulse Platform Receives FDA Approval for Atrial Fibrillation Treatment
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Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Varipulse platform, marking a significant advancement in the treatment of drug refractory paroxysmal atrial fibrillation (AFib). The Varipulse platform is the company’s first pulsed field…
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Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System
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Germany-based Bayer AG (ETR: BAYN) has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MEDRAD Centargo CT Injection System. This innovative multi-patient injector is designed to enhance workflow efficiency and integrates seamlessly with Bayer’s existing portfolio of products, particularly in high-volume…
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Siemens Healthineers AG Reports Fiscal 2024 Results with Targeted Revenue Growth
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Germany-based medical device giant Siemens Healthineers AG (ETR: SHL) has released its financial results for the fourth quarter of fiscal 2024, ended September 30, 2024, and the full fiscal year 2024. The company achieved its targets for revenue growth and earnings per share for FY2024, demonstrating resilience amidst challenging market…
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China’s NHC Announces Initiative to Boost Gerontology Medical Services
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The National Health Commission (NHC) has issued a notification aimed at enhancing gerontology medical service capabilities, outlining specific work requirements. These include the construction of geriatric medicine departments, development of geriatric medical talent teams, standardization of geriatric medical diagnosis and treatment services, and enrichment of service models. Improving Geriatric Medicine…
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Boston Scientific Launches Vercisie Genius DBS System in China for Parkinson’s Disease Treatment
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US major Boston Scientific Corporation (NYSE: BSX) has officially launched its Vercisie Genius, an implantable deep brain stimulation (DBS) system, at the 7th CIIE. This move is set to enhance the treatment options available to China’s growing Parkinson’s disease (PD) population. Parkinson’s Disease and Deep Brain Stimulation TherapyParkinson’s disease (PD),…
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China’s NMPA Issues Guidelines for Domestic Manufacturing of Imported Medical Devices
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The National Medical Products Administration (NMPA) has released a notification aimed at further clarifying the regulations surrounding the manufacturing of imported medical devices by companies within China. The document is open for public feedback until December 2, 2024. Requirements for Domestic Production of Certified Imported DevicesThe document stipulates that for…
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Shanghai HeartCare Medical Technology Receives NMPA Approval for Embolization Stent
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China’s National Medical Products Administration (NMPA) has granted marketing approval to Shanghai HeartCare Medical Technology Co., Ltd (HKG: 6609) for its innovative intracranial aneurysm embolization assisted stent. This product is now cleared for use in clinical standard interventional surgical settings for intravascular embolization and blood flow reconstruction in patients diagnosed…
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NMPA Grants Marketing License to Abonisi Medical Technology’s Knee Joint Prosthesis System
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China’s National Medical Products Administration (NMPA) has issued a marketing license to Abonisi Medical Technology (Suzhou) Co., Ltd. for its knee joint prosthesis system, a significant advancement for domestic medical device innovation. Innovative Design of the Knee Joint Prosthesis SystemThe knee joint prosthesis system, designed for first-time knee replacement surgery…
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J&J MedTech Completes Pilot Enrollment for OMNY-AF Study on Atrial Fibrillation Treatment
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US major Johnson & Johnson (J&J, NYSE: JNJ) MedTech has announced the completion of pilot phase enrollment for the OMNY-AF study, which is assessing the effect of its OMNY-AF platform in symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia. The single-arm, multi-center study aims to enroll up…
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Suzhou Basecare Medical’s BKA210 Receives Marketing Approval in Jiangsu Province
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China-based in vitro fertilization (IVF) specialist Suzhou Basecare Medical Co., Ltd (HKG: 2170) has announced that it has received marketing approval for its intelligent sperm quality analyzer, BKA210, in Jiangsu province. This marks the world’s first device capable of detecting unstained live sperm, offering a significant advancement in the field…
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Jenscare Scientific’s LuX-Valve Plus Shows Positive One-Year Results in TRAVEL II Study
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Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced the one-year follow-up results from the multi-center TRAVEL II study for its transjugular tricuspid valve replacement product, LuX-Valve Plus, at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual meeting in Washington. The TRAVEL II study, which assesses…
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Jiangsu Yuyue Medical Equipment Partners with TÜV SUD to Boost Medical Device Market Access
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Jiangsu Yuyue Medical Equipment Inc., (SHE: 002223), a Chinese medical equipment manufacturer, has entered into a strategic partnership with Germany’s TÜV SUD, one of the world’s largest technical inspection institutions. The collaboration aims to enhance their cooperation in the medical device market access and quality system. With over two decades…
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Acotec Secures NMPA Approval for Acotrace Disposable Catheter Sheath
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Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received marketing approval from the National Medical Products Administration (NMPA) for its Acotrace, a disposable catheter sheath group. The Acotrace is designed for the insertion of medical devices, including guide wires and catheters, into blood vessels, facilitating percutaneous puncture access…
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Sino Medical Reports Five-Year PIONEER Study Results for HT Supreme Stent System
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Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced the five-year follow-up results from the Phase III PIONEER study for its first-in-class HT Supreme drug-eluting stent system across the United States, Japan, and Europe. The HT Supreme system represents a significant milestone as the first cardiac stent…
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Mindray Reports Q3 2024 Financials: International Revenues Surge Over 18% Amid Domestic Challenges
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (SHE: 300760) reported its Q3 2024 financial results, revealing revenues of RMB 29.48 billion (USD 4.18 billion) for the first three quarters, reflecting a year-on-year increase of 7.99%. Net profit attributable to the parent company reached RMB 10.64 billion (USD 1.49 billion), up 8.16%…
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Wantai Biological’s P85 Ab Detection Kit Receives NMPA Approval for Nasopharyngeal Carcinoma Screening
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a Chinese pharmaceutical company, announced last week that it has received marketing approval from the National Medical Products Administration for its EB virus BNLF2b antibody (P85 Ab) detection kit, which utilizes the magnetic particle chemiluminescence method. This product is a collaborative…
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Shanghai MicroPort Initiates Pre-Marketing Clinical Study for Embolic Microspheres in Liver Cancer Treatment
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical technology company, has announced the commencement of a pre-marketing clinical study for its polyvinyl alcohol embolic microspheres. The company has completed the first pre-marketing clinical implantation in transcatheter arterial chemoembolization (TACE) surgery for left lobe lesions in patients with…
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Sino Medical Sciences Technology Secures Marketing Approval for Coronary Balloon Dilation Catheter in Morocco
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Sino Medical Sciences Technology Inc., (SHA: 688108) a China-based medical device company, has announced that it has received marketing approval in Morocco for its SC HONKYTONK coronary balloon dilation catheter. This product, designed for balloon catheter dilation of narrowed segments or bridging sites in coronary arteries to enhance myocardial perfusion,…
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China Grand Pharmaceutical Receives NMPA Approval for Innovative Adjustable Thrombectomy Stent
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China Grand Pharmaceutical and Healthcare Holdings Ltd (CGP; HKG: 0512) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its adjustable intracranial thrombectomy stent, marking a significant milestone as the first domestically produced device of its kind in China for the treatment of…
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German Endoscope Maker KARL STORZ Secures Marketing Approval for Disposable Ureteroscope in China
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KARL STORZ SE & Co. KG, a leading German endoscope manufacturer, has announced that it has received marketing approval in China for its FLEX-XC1, a disposable electronic ureteroscope. This new product employs cutting-edge imaging technology to offer a broader field of view, ensuring ample brightness and detailed visibility of the…
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Thermo Fisher’s Oncomine Dx Target Test Gets FDA Green Light as Companion Diagnostic for Servier’s Voranigo
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US pharmaceutical and biotechnology company Thermo Fisher Scientific (NYSE: TMO) has received marketing approval from the US Food and Drug Administration (FDA) for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets. Voranigo, the first…
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Guangzhou Releases First Batch of Innovative Drugs and Medical Devices List, Featuring Local Companies
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The Guangzhou Municipal Industry and Information Technology Bureau has unveiled the first batch of innovative drugs and medical devices included in the city’s list, with 24 products making the shortlist. This initiative is aimed at promoting local innovation and development within the pharmaceutical and medical device sectors. Among the notable…
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Dongcheng Pharma Moves to Enhance Portfolio with Acquisition of Rongcheng Medical’s GSA Injection
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) has announced its intention to acquire full rights to the 99mTc GSA Injection and GSA cold kit from domestic rival Rongcheng Medical Technology Wuxi Co., Ltd., for a purchase price of RMB 85 million (approximately USD 11.82 million). The 99mTc GSA…
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MicroPort Sorim CRM’s PLATINIUM Series ICD Receives NMPA Approval, A First for China
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MicroPort Sorim CRM, a Chinese medical device company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its PLATINIUM series implantable cardioverter defibrillator (ICD). This marks a significant milestone as the PLATINIUM series becomes the first domestically developed ICD in China. The approved…
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MicroPort CardioFlow’s Heart Valve Balloon Dilatation Catheter Alwide Plus Gains Mexican Approval
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MicroPort Scientific Corp., a leading Chinese medical device company (HKG: 0853), through its spin-off MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has announced that it has received market approval for its heart valve balloon dilatation catheter, Alwide Plus, from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) in…
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Novocure’s Optune Lua Wins FDA Approval for mNSCLC Treatment in Combination with Immunotherapies
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Novocure (NASDAQ: NVCR), a Swiss firm renowned for its pioneering Tumor Treating Fields (TTFields) cancer therapy, has received marketing approval from the US Food and Drug Administration (FDA) for its Optune Lua device. This portable device is now cleared for use in combination with PD-1/PD-L1 inhibitors or docetaxel to treat…
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Lepu Medical Receives Approval for Noninvasive Blood Glucose Meter NeoGlu 01 in China
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions in China, has announced that it has received marketing approval from the National Medical Products Administration for its innovative product, NeoGlu 01, a noninvasive blood glucose meter. This new device combines optical and thermal methods…
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Roche’s VENTANA CLDN18 Assay Receives EU Approval, Enhances Targeted Therapy Options for Gastric Cancer
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Roche (SWX: ROG; OTCMKTS: RHHBY) has secured CE Mark approval in the European Union for its VENTANA CLDN18 (43-14A) RxDx Assay, marking a pivotal advancement in the treatment landscape for gastric cancer. This immunohistochemistry (IHC) companion diagnostic (CDx) test is the first to determine CLDN18 protein expression in tumors of…
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Sunvozertinib’s Companion Diagnostic Gets NMPA Nod, Fortifying Targeted Therapy Arsenal for NSCLC in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib,…
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Sino Medical Sciences Secures NMPA Nod for Balloon Guided Catheter to Aid Vascular Procedures
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its balloon guided catheter. The device is designed to assist in the insertion of intravascular catheters and guide them into the target vessel within the peripheral…
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MicroPort Endovascular MedTech’s Fiber Wool Plug Spring Coil Gains NMPA Marketing Approval
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) has received marketing approval from the National Medical Products Administration (NMPA) for its fiber wool plug spring coil, a device used for the filling treatment of peripheral vascular aneurysms, arteriovenous malformations, and arteriovenous fistulas. The spring coil is constructed from a platinum…
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LenoMed Medical’s Touch-Insulin Pump Receives NMPA Approval, Aids China’s Diabetes Management
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Shanghai-based LenoMed Medical, a medical device platform company backed by Legend Capital and Legend Star, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed touch-insulin pump. This product, which boasts an infusion accuracy of 0.01U per hour, is lauded as…
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Sansure Biotech’s HPV Detection Kit Receives NMPA Approval for Comprehensive Screening
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Sansure Biotech Inc., a molecular diagnostics specialist based in China and listed on the Shanghai Stock Exchange (SHA: 688289), has announced that it has received marketing approval from the National Medical Products Administration for its human papillomavirus (HPV) nucleic acid detection kit. This kit, which uses the PCR fluorescent probe…
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ClouDr Receives NMPA Green Light for ClouDT-01, a Groundbreaking Digital Diabetes Treatment
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Hangzhou Kang Ming Information Technology Co., Ltd, trading under the banner of “ClouDr” on the Hong Kong stock exchange (HKG: 9955), has announced that it has secured marketing approval from the National Medical Products Administration (NMPA) for its innovative digital medicine product, ClouDT-01, designed for the treatment of diabetes. Leveraging…
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Huadong Medicine’s V20 Device Receives NMPA Approval for Market Launch
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category III medical device, V20. The V20 is an intense pulsed light radiofrequency therapy device designed for various dermatological treatments. The V20 therapeutic…
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Acotec Scientific’s Heart Valve Balloon Dilatation Catheter RunFlow Wins NMPA Approval
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Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product RunFlow, a heart valve balloon dilation catheter. Designed for autologous valve dilation of the aorta during artificial aortic…
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Hainan Province Approves Heart-Lung Walking Test Analysis Software as Category II Device
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The Hainan Medical Products Administration has granted marketing approval to a heart-lung walking test data analysis software following a priority review process. This digital therapy product, classified as a Category II medical device, is designed to assist healthcare professionals in evaluating patients’ exercise cardiopulmonary function, excluding automatic diagnosis. The approval…
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China’s NMPA Releases Standards for Brain-Computer Interface Medical Devices
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The National Medical Products Administration (NMPA) in China has issued a notification confirming the establishment of two new standards related to medical devices utilizing Brain-Computer Interface (BCI) technology. The first standard, titled “Terminology and Definitions for Medical Devices Using Brain Computer Interface (BCI) Technology,” aims to provide a clear framework…
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MicroPort Scientific’s Firesorb Bioabsorbable Stent Begins Clinical Use in China
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MicroPort Scientific Corp., a leading medical device company based in Shanghai (HKG: 0853), has announced the initial clinical applications of its new-generation bioabsorbable stent, Firesorb, across seven clinical centers in five Chinese cities. The product received marketing approval in China in July this year. Firesorb is a bioabsorbable rapamycin targeted…
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Hangzhou-Based Ophthalmic Device Maker MDCO Secures RMB 200 Million in Series B Funding
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MDCO, an ophthalmic medical device company headquartered in Hangzhou, has reportedly secured nearly RMB 200 million in a Series B financing round. The funding was led by Hangzhou Qiantang Heda Bio-medical Investment Fund, Sunland Capital, and existing investor Decheng Capital. The capital raised will be allocated to bolster the company’s…
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Yestar Healthcare’s 2024 Interim Report Reflects Impact of Volume-Based Procurement on Revenue
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Yestar Healthcare Holdings Co., Ltd., a leading distributor and service provider for in vitro diagnostic (IVD) reagents and products in China, has released its interim report for 2024. The report indicates a 13.5% year-on-year (YOY) decrease in the company’s overall revenue for the first half of the year, amounting to…
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Siemens Healthineers’ 7T MRI System Terra. X Receives NMPA Marketing Approval
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Siemens Healthineers AG has secured marketing approval from China’s National Medical Products Administration (NMPA) for its Magnetom Terra X, a localized next-generation 7T magnetic resonance imaging (MRI) system. This marks a significant advancement in medical imaging technology within the Chinese market. Terra. X, the first domestically produced 7T clinical MRI…
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Medtronic Secures China Market Approval for Pulsed Electric Field Atrial Fibrillation Treatment Devices
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Medtronic (NYSE: MDT), the US-Irish medical technology giant, has announced that it has received approvals from Chinese regulatory authorities for its innovative heart pulse electric field ablation device and disposable heart pulse electric field ablation catheter. These products, when used in tandem, employ the non-thermal effects of pulsed electric fields…
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Amoy Diagnostics’ AiHuiJie Lung Cancer Companion Diagnostic Receives NMPA Approval
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its AiHuiJie, a companion diagnostic (CDx) reagent designed for lung cancer. This PCR-based product is capable of detecting 11 key driver…
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Edwards Lifesciences Sells ICU Business to BD in $4.2 Billion Deal, Announces Layoffs
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Edwards Lifesciences, a leading U.S. medical device company, has reportedly reached an agreement to sell its intensive care unit (ICU) business to fellow U.S. firm BD for USD 4.2 billion. This strategic move is accompanied by a global restructuring that will result in layoffs impacting approximately 3% of the company’s…
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Genesis MedTech Secures NMPA Approval for Innovative Surgical Energy Products
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Genesis MedTech, a leading medical device company headquartered in Singapore, has secured marketing approvals from China’s National Medical Products Administration (NMPA) for two of its high-frequency electrosurgical energy products: the “OP9 ultrasonic high frequency integrated surgical equipment” and the “disposable cutting and closing knife head.” The OP9 device is a…
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True Health’s Advanced Microwave Ablation System Gains NMPA Nod for Liver Tumor Treatment
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True Health (Guangdong Hengqin) Medical Technology Co., Ltd has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative navigation positioning microwave ablation system. This advanced medical device utilizes CT images to devise a precise needle insertion plan prior to surgery and provides real-time guidance for the…
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Venus Medtech Initiates Global Study with Venus Vitae TAVR System Implantations
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Venus Medtech (Hangzhou) Inc., listed on the Hong Kong Stock Exchange as HKG: 2500, has reached a significant milestone with the implantation of its next-generation transcatheter aortic valve replacement (TAVR) system, Venus Vitae, in two patients as part of the global, multi-center pivotal SMART-ALIGN study. This prospective, randomized, interventional study…
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Sansure Biotech Wins NMPA Nod for ALDH2 Gene Polymorphism Detection Kit
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Sansure Biotech Inc., (SHA: 688289), a leading molecular diagnostics company based in China, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for its nucleic acid detection kit for the human ALDH2 gene polymorphism, utilizing the PCR fluorescent probe method. The kit is designed…
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Jafron Biomedical’s Blood Purification Devices Gain EU Market Approval Under MDR
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Jafron Biomedical Co., Ltd, a prominent player in the blood purification sector based in China, has announced that its Category III medical devices, the cytokine adsorption column and the disposable blood perfusion device, have secured market approvals within the European Union. This approval is in accordance with the stringent Medical…
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Beijing Balance Medical Secures NMPA Nod for Renatus Transcatheter Aortic Valve System
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BEIJING—Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has received market approval from the National Medical Products Administration (NMPA) for its Renatus transcatheter aortic valve system. This in-house developed product is now approved for use in patients aged 70 years or older who are diagnosed with symptomatic, calcified, and severe…
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Sino Medical Sciences Secures Hong Kong Approval for Coronary Balloon Dilation Catheter
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HONG KONG—Sino Medical Sciences Technology Inc., (SHA: 688108), a leading medical device company based in China, has announced that it has received marketing approval in Hong Kong for its SC HONKYTONK coronary balloon dilation catheter. This approval marks a significant expansion of the product’s reach, as it is already registered…
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MicroPort CardioFlow to Acquire RMB 380 Million Shanghai Assets for Global HQ Expansion
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China-based MicroPort Scientific Corp. (HKG: 0853) has announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), will acquire a 100% stake in Shanghai Heart Forever Medical Technology Co., Ltd. The acquisition, valued at up to RMB 380 million, will be executed through a transfer from its sister company,…
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NMPA Suspends Jeisys Medical Inc.’s Nd:YAG Laser Equipment Over Quality Concerns
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BEIJING—The National Medical Products Administration (NMPA) of China has issued a notification to immediately suspend the import, operation, and use of Nd:YAG laser surgery equipment manufactured by South Korea-based Jeisys Medical Inc. The decision comes in the wake of a remote non-site inspection, which revealed critical deficiencies in the company’s…
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Advancing Peripheral Artery Disease Care: Boston Scientific’s JETSTREAM Receives Marketing Nod in China
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NEW YORK—Boston Scientific Corporation (NYSE: BSX), a leading innovator in medical solutions, has secured a significant regulatory milestone with the National Medical Products Administration’s (NMPA) marketing approval for its JETSTREAM vascular plaque rotary cutting system. This development marks a significant step forward in the treatment of peripheral arterial disease (PAD)…
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Chinese NMPA Grants License to MicroPort Endovascular MedTech’s Venous Stent for Treating Vascular Conditions
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Shanghai MicroPort Endovascular MedTech Co., Ltd, a Chinese endovascular device manufacturer listed on the Shanghai Stock Exchange (SHA: 688016), has received a Category III medical device license from China’s National Medical Products Administration (NMPA) for its venous stent system. This product was granted special review status as an innovative medical…
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Suzhou-Based Medical Device Innovator Ensurge Secures RMB 100 Million in Latest Financing Round
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Ensurge, a cutting-edge medical device manufacturer headquartered in Suzhou, is reportedly in the spotlight for securing a new round of financing that has yielded RMB 100 million. The funding round saw participation from a consortium of investors including TPIC, Legend Capital, and Peakview Capital. The capital raised is earmarked for…
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National Healthcare Security Administration Reports Pricing Revisions on Aortic Stent Grafts by Major Manufacturers
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The National Healthcare Security Administration (NHSA) has reported that 12 device manufacturers, both domestic and international, have revised the pricing of their thoracic aortic stent graft products. Among these companies are the US-Irish firm Medtronic (NYSE: MDT), Shanghai-based MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), W. L. Gore & Associates,…
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Allgens Medical Technology’s BonGold Receives Marketing Approval from Malaysia’s MDA
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Allgens Medical Technology Co., Ltd, a Beijing-based innovator in regenerative medicine materials and implantable devices listed on the Shanghai Stock Exchange (SHA: 688613), has secured marketing approval from the Medical Device Authority (MDA) of Malaysia for its flagship product, BonGold, an artificial bone repair material. BonGold is a biomimetic mineralized…
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Bone Index Secures Financing to Expand Manufacturing and Promote Diagnostic Technology Globally
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Bone Index, a Finland-based medical technology company specializing in bone diagnostics, has announced the successful completion of a new financing round, with the exact amount remaining undisclosed. The round was spearheaded by Lynx Financial, a Shanghai-based fund with a dedicated focus on healthcare and life sciences, and was supported by…
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Finland’s Bone Index Partners with Lynx Financial for APAC and North American Market Expansion
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HELSINKI—Bone Index, a pioneering medical technology company headquartered in Finland, has announced the successful completion of a new financing round, with the exact amount remaining undisclosed. The round was led by Shanghai-based Lynx Financial, a fund with a dedicated focus on healthcare and life sciences, and was supported by contributions…
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MicroPort MedTech’s ReeAmber Catheter Wins NMPA Nod for Peripheral Artery Treatments
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SHANGHAI—Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a leading player in the medical device industry, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its ReeAmber peripheral balloon dilation catheter. This next-generation device is designed to address a broad spectrum of vascular…
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China’s NMPA Grants Medical Device License to DaAn Gene’s Monkeypox Detection Kit
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GUANGZHOU—DaAn Gene Co., Ltd, a subsidiary of Sun Yat-sen University based in China (SHE: 002030), has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its Monkeypox virus nucleic acid detection kit, which utilizes the fluorescence PCR method. This development is significant…
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Lepu Medical Secures Approval for RECATCHOR Catheter, Enhancing Cardiovascular Procedures
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions in China, has secured marketing approval from the National Medical Products Administration for its innovative RECATCHOR device. This anchored balloon dilation catheter is designed to facilitate the anchoring of guidewires and assist in the exchange…
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Robotrak Secures NMPA License for China’s First Smart Ophthalmic Navigation Laser
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Robotrak, a Nanjing-based ophthalmic innovation platform, has secured a Category III medical device license from the National Medical Products Administration (NMPA) for its cutting-edge smart ophthalmic navigation laser. This marks the first such device of its kind in China. The all-solid-state laser photocoagulation device offers a suite of advanced features,…
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Lepu Scientech Secures NMPA Approval for MemoSORB Biodegradable Atrial Septal Defect Occluder
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd. (HKG: 2291) has announced that it has received a medical device license from China’s National Medical Products Administration (NMPA) for its innovative MemoSORB biodegradable atrial septal defect occluder. This cutting-edge device offers significant advantages over traditional nitinol occluders by markedly reducing inflammatory responses,…
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Sino Medical Secures Moroccan Approvals for NC Rockstar Catheter and HT Supreme Stent System
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Sino Medical Sciences Technology Inc. (SHA: 688108), a prominent player in China’s medical device sector, has secured marketing approvals in Morocco for its NC Rockstar non-compliant coronary artery balloon dilation catheter and the HT Supreme drug-eluting stent system. The NC Rockstar catheter is designed for balloon dilation of autologous coronary…
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Shanghai Sanyou Medical to Acquire Full Control of SMTP Technology for RMB 415.7 Million
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Shanghai Sanyou Medical Co., Ltd. (SHA: 688085), based in China, is set to acquire the remaining 48.2% stake in SMTP Technology Co., Ltd. that it does not already own, in a transaction valued at RMB 415.7 million (approximately USD 58.2 million). SMTP Technology is a high-tech medical device company focused…
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China’s Sansure Biotech Launches Approved Kit for Alzheimer’s and Cardiovascular Risk Assessment
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Sansure Biotech Inc. (SHA: 688289), a China-based leader in molecular diagnostics, has secured marketing approval from the National Medical Products Administration (NMPA) for its human ApoE gene polymorphism nucleic acid detection kit, utilizing the PCR fluorescent probe method. This kit is classified as a Category III medical device. The detection…
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Lepu Medical’s PeakHeat Vascular Sheath Gains Regulatory Green Light for Market Launch
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions in China, has secured marketing approval from the National Medical Products Administration for its PeakHeat disposable vascular sheath. This innovative product facilitates the percutaneous insertion of vascular systems, enabling the introduction of medical devices such…
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Artech Medical’s Balloon Cryoablation Catheter Wins NMPA Nod for Atrial Fibrillation Treatment
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Shanghai Artech Medical Technology Co., Ltd., a company known for its innovation in the medical device sector, has received marketing approval from China’s National Medical Products Administration (NMPA) for its balloon cryoablation catheter, a groundbreaking product designed for the treatment of paroxysmal atrial fibrillation. This novel device marks a significant…
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Sansure Biotech’s MTHFR Gene Detection Kit Receives NMPA Approval, Aids in Pregnancy Health Management
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Sansure Biotech Inc. (SHA: 688289), a specialist in molecular diagnostics based in China, has achieved a regulatory milestone with the National Medical Products Administration (NMPA) granting marketing approval for its in-house developed human MTHFR gene polymorphism nucleic acid detection kit, which utilizes the PCR fluorescent probe method. This product is…
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Vazyme Biotech Secures NMPA Nod for Two RSV Antigen Detection Kits
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Vazyme Biotech Co., Ltd (SHA: 688105), a biotechnology company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for two of its respiratory syncytial virus (RSV) detection kits. The newly approved products include the RSV antigen detection kit utilizing the colloidal…
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Israeli Hair Transplant Innovator Hairstetics Launches First Procedure in Asia at Hainan Hospital
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Hairstetics, an Israeli innovator in the non-absorbable polyamide hair transplant sector, has achieved a milestone with the implementation of its system at Hainan Boao LuYi Hospital, marking the first use case in Asia. The company’s cutting-edge technology addresses the complex and often slow-progressing condition of female androgenetic alopecia, a disease…
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United Imaging Healthcare Launches Medical-Grade Hearing Aid uOrigin in China
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United Imaging Healthcare Technology Co., Ltd (UIH), a leading player in the medical imaging and healthcare industry, has announced the official launch of its medical-grade hearing aid, uOrigin, in the Chinese market. This move marks the company’s expansion into the audiology sector, offering a new solution for individuals with hearing…
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Sino Medical Sciences’ HT Supreme Drug-Eluting Stent System Gains Market Approval in Mexico
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Sino Medical Sciences Technology Inc. (SHA: 688108), a prominent player in the medical device industry in China, has announced that its HT Supreme drug-eluting stent system has received marketing approval in Mexico. This development marks a significant expansion of the company’s global footprint. The HT Supreme system is a state-of-the-art…
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Roche’s Alzheimer’s Disease Diagnostic Kits Gain Approval in Hainan, Set for Use in Shanghai Ruijin Hospital
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Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has received approval from the Hainan Medical Products Administration for its suite of Alzheimer’s disease (AD) cerebrospinal fluid diagnostic kits. The approved products include Elecsys β-Amyloid (1-42) CSF II, Elecsys Phospho Tau (181P) CSF, Elecsys Total Tau CSF detection reagents, along with…
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AbbVie’s Allergan Aesthetics Wins NMPA Approval for Juvéderm Dermal Filler in China
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has secured marketing approval from China’s National Medical Products Administration (NMPA) for its Juvéderm product line, specifically the Juvéderm越致 dermal filler. This crosslinked sodium hyaluronate gel, which includes lidocaine for comfort during treatment, is designed for injection into the middle to deep…
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MicroPort Scientific’s Bioabsorbable Stent System Gains NMPA Nod for Ischemic Heart Disease Treatment
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Shanghai-based medical device conglomerate MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its proprietary bioabsorbable rapamycin eluting coronary stent system. This innovative device is designed for the treatment of patients suffering from ischemic heart disease due to…
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MicroPort Scientific’s Fully Biodegradable Cardiac Stent Earns NMPA Nod
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Shanghai-based medical device titan MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its new generation fully biodegradable and absorbable cardiac stent. This innovation marks a significant advancement in the field of interventional cardiology. The stent is the…
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ShuWen Biotech’s Preeclampsia Self-Test Receives NMPA Approval, Marking a Global First
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Zhejiang-based ShuWen Biotech Co., Ltd has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative CercaTest Red, a patented self-test designed for household use by pregnant women to screen for preeclampsia. This marks the first time a self-test of this kind has…
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Shanghai Sanyou Medical Gains NMPA Approval for 3D Printed Cervical Fusion Device
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Shanghai Sanyou Medical Co., Ltd (SHA: 688085), a prominent player in the medical device industry in China, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its innovative 3D printing metal additive manufacturing cervical fusion device. This breakthrough product…
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Beijing Balance Medical Secures NMPA Nod for Pioneering Heart Valve Patch
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198), a leading medical technology firm based in China, has achieved a significant regulatory milestone with the National Medical Products Administration’s (NMPA) approval for its heart valve biological patch. This marks the first market approval for a product specifically designed for the repair…
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MicroPort MedTech’s Aortic Occlusion Catheter Gets Green Light from China’s NMPA
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a leading player in the medical technology sector, has secured a significant regulatory milestone with its aortic occlusion balloon catheter receiving marketing approval from China’s National Medical Products Administration (NMPA). This product, designed for temporary blood flow obstruction in the aorta, marks…
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Lepu Scientech Secures NMPA Approval for RF Lance, Advancing Atrial Septal Puncture Technology
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd (HKG: 2291), a leading medical technology company based in China, has announced that it has obtained a medical device license from the National Medical Products Administration (NMPA) for its RF Lance, a novel disposable radiofrequency atrial septal puncture needle. This product is designed…
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Amoy Diagnostics’ APACE Receives Japanese Approval as Companion Diagnostic for MET-Inhibiting Therapies
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a Chinese diagnostics company, has announced that it has received two new indication approvals in Japan for its APACE (also known as PCR-11 gene product), a multi-target rapid screening product designed for lung cancer detection. The product is now approved as a companion…
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Edwards Lifesciences to Acquire Peijia Medical’s US Partner JenaValve, Impact on Licensing Deal Minimal
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China-based Peijia Medical Ltd (HKG: 9996) has announced that its US-based partner JenaValve Technology Inc. will be acquired by Edwards Lifesciences Corporation through a merger agreement. This strategic acquisition comes as part of Edwards Lifesciences’ efforts to strengthen its structural heart portfolio. JenaValve had entered into a licensing agreement with…
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Hangzhou Jianjia Medical’s Arthbot Surgical Robot Receives NMPA Approval for Orthopedic Procedures
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Hangzhou Jianjia Medical Technology Co., Ltd has received marketing approval from China’s National Medical Products Administration (NMPA) for its Arthrobot surgical robot, a significant step for the company as it looks to enhance precision in orthopedic procedures. The Arthbot is a multifunctional device capable of performing joint replacement surgeries, including…
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MicroPort CardioFlow Secures Exclusive Distribution Rights for Evermend Occluders in China
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MicroPort Scientific Corp (HKG: 0853), a leading medical device company based in China, has announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has entered into a distribution framework agreement with Dongguan Kewei Medical Instrument Co., Ltd. Kewei, which was acquired by MicroPort Scientific in 2012, has agreed…
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MicroPort MedTech’s Vepack Filter Retriever Earns NMPA Marketing Approval
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a prominent medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Vepack filter retriever. The Vepack system, comprising a catcher and a sheath/expander, is designed to percutaneously remove…
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Venus Medtech’s VenusP-Valve Receives Marketing Approval in Venezuela, Expanding Global Reach
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Venus Medtech (Hangzhou) Inc., (HKG: 2500), a leading medical device company, has announced that it has received marketing approval for its VenusP-Valve, a transcatheter pulmonary valve replacement (TPVR) system, in Venezuela. This marks another significant milestone for the company, as VenusP-Valve is the first self-expanding TPVR product to be approved…
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Shanghai Sanyou Medical’s Cervical Thoracic Internal Fixation System Earns NMPA Approval
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Shanghai Sanyou Medical Co., Ltd (SHA: 688085), a leading medical device company based in China, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its cervical thoracic internal fixation system. This innovative product suite, which includes advanced implants and…
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United Imaging Expands Latin America Footprint with Pediatric uMI 550 PET/CT Launch in Mexico
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United Imaging, a leading Chinese medical device manufacturer, has announced the launch of its uMI 550 PET/CT system in Mexico, marking a significant step in the company’s expansion into Latin America. The advanced imaging system has been installed at Mexico’s National Institute for Pediatric Care (INP), highlighting the device’s specialized…
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Mindray Bio-Medical Partners with Nanjing Municipal Government to Boost Healthcare Innovation
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd (SHE: 300760), a leading player in the global medical device market, has entered into a strategic partnership with the municipal government of Nanjing. This collaboration aims to drive an extensive, multi-tiered, and broad application of scientific research achievements within the healthcare sector, enhancing both…
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Medtronic Launches Advanced Signia Stapler in China, Expanding Surgical Capabilities
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Medtronic (NYSE: MDT), the US-Irish medical device giant, has announced the launch of its intelligent surgical stapler, the Signia Stapler, in China. This new device is set to enhance surgical procedures with its advanced features. Originally designed for open surgery, the stapler’s application scenarios have expanded to include laparoscopic surgery,…
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Haohai Biotech’s Sodium Hyaluronate Gel Receives NMPA Approval for Aesthetic Treatments
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Shanghai Haohai Biology Science & Technology Co., Ltd (HKG: 6826, SHA: 688366) has announced that it has received Medical Device Registration Approval from the National Medical Products Administration for its innovative amino acid cross-linked sodium hyaluronate gel. The product is indicated for injection into the middle to deep layers of…
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China Isotope & Radiation Corporation Secures NMPA License for Innovative Radiotherapy System
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China Isotope & Radiation Corporation (CIRC; HKG: 1763) has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its innovative gamma beam stereotactic radiotherapy system. This new system represents a significant advancement in the field of radiation therapy. The product streamlines the…
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Hugo Biotech Partners with Watchmaker Genomics to Develop Infectious Disease Detection Solutions
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Hugo Biotech, a biotech company based in Beijing, has entered into a partnership with Watchmaker Genomics, a U.S.-based provider of innovative molecular analysis solutions, to collaborate in South Africa. The collaboration aims to combine their respective R&D strengths to develop more sensitive, user-friendly, and cost-effective infectious disease detection products. The…
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Boston Scientific’s FARAPULSE Pulse Field Ablation System Earns NMPA Approval
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Boston Scientific Corporation (NYSE: BSX), a leading medical device company in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its FARAPULSE pulse field ablation system. This system includes the FARAWAVE disposable cardiac pulse field ablation catheter and the FARASTAR cardiac…
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Xinzeyuan Medical Technology Secures Over RMB 100 Million in Series B Financing
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Xinzeyuan Medical Technology Co., Ltd, a Hangzhou-based micro invasive medical device supply chain platform, has reportedly secured over RMB 100 million (USD 13.8 million) in a Series B financing round. The round was led by Qiming Venture Partners, with Silicon Paradise also participating in the funding. The company plans to…
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Blue Sail Medical’s Fastroad Catheter Earns NMPA Marketing Approval
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Blue Sail Medical Co., Ltd (SHE: 002382), a medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category III medical device, Fastroad. Fastroad is a distal pathway catheter designed for radial artery neurovascular access and was…
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Jiangsu Vcare Pharma Partners with Geneseeq Technology to Develop Companion Diagnostic for NTRK Inhibitor
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Jiangsu Vcare PharmaTech Co., Ltd, a biopharmaceutical company based in China, has entered into a partnership with Sino-Canadian firm Geneseeq Technology Inc. The collaboration aims to jointly develop and commercialize a companion diagnostic (CDx) reagent for Vcare’s NTRK inhibitor VC004. Financial details of the agreement were not disclosed. Preliminary clinical…
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Cryofocus Biotechnology Partners with Boston Scientific for Respiratory Products Distribution in China
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Cryofocus Biotechnology Co., Ltd (HKG: 6922), a Shanghai-based specialist in cryoablation treatment, has announced a strategic distribution agreement with the Shanghai subsidiary of US medical device giant Boston Scientific Corporation (NYSE: BSX). As per the terms of the agreement, Cryofocus is set to become the exclusive marketing partner and sales…
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Ningbo-Based Jenscare Scientific Announces Successful Follow-up Data for Transjugular Tricuspid Valve Device
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading manufacturer of structural heart disease devices headquartered in Ningbo, has announced the six-month follow-up results from the multi-center TRAVEL II study for its transjugular tricuspid valve replacement product, LuX-Valve Plus. The TRAVEL II study, a prospective, multi-center, single-arm clinical trial, was designed…
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MicroPort Endovascular to Fully Acquire Optimum Medical Device in $65M Deal
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a leading Chinese medical technology company, has declared its intention for its wholly-owned subsidiary, MicroPort Endovastec B.V., to acquire a controlling 72.37% stake in Optimum Medical Device Inc. (OMD) for a transaction valued at USD 65 million. Following the completion of this…
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Jiangsu Yuyue Medical Teams Up with China Unicom for Digital Healthcare Innovation
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Shanghai-based Jiangsu Yuyue Medical Equipment Inc. (SHE: 002223) has announced a strategic partnership with China Unicom, aiming to enhance digitalization in enterprise management, product digitization, and global technological empowerment. China Unicom will utilize its network, cloud, communication technology, and AI algorithms to advance the intelligence and digital upgrade of Yuyue’s…
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Hybribio Ltd Secures NMPA Approval for α-Thalassemia Genotyping Detection Kit
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Hybribio Ltd (SHE: 300639), a Guangdong-based provider of nucleic acid molecular diagnostic products, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its α-thalassemia genotyping detection kit. The kit, which utilizes PCR and flow cytometry technology, is designed for qualitative detection of 10…
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Zhejiang Dian Diagnostics Partners with Quest Diagnostics to Advance Alzheimer’s Disease Blood Tests
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Zhejiang Dian Diagnostics Co., Ltd (SHE: 300244), a leading diagnostics company based in China, has entered into a strategic partnership with Quest Diagnostics, a top global provider of diagnostic information services. The collaboration aims to develop and offer blood-based clinical research services specifically tailored for Alzheimer’s disease (AD). Through this…
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Accuray Wins Chinese Nod for Precision Treatment Planning System, Boosting Regional Expansion
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U.S. medical device company Accuray Inc. (NASDAQ: ARAY) has announced that it has received market approval from Chinese regulatory authorities for its Accuray Precision Treatment Planning System (TPS). This approval will enable the integration of the TPS with the Tomo C radiation therapy system, which is part of the CNNC-Array…
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Sansure Biotech’s Tuberculosis Detection Kit Gains CE IVDR Certification for EU Market
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Sansure Biotech Inc. (SHA: 688289), a leading molecular diagnostics company based in China, has announced that it has received CE IVDR certification from the European Union for its mycobacterium tuberculosis nucleic acid detection kit, which utilizes the PCR fluorescence probe method. This certification marks a significant milestone, as it grants…
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MicroPort Endovascular MedTech Secures NMPA Approval for Vena Cava Filter
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a prominent medical device company based in China, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its newly developed vena cava filter. This device is designed to be percutaneously inserted…
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Rightongene Bio Receives NMPA Approval for BCR-ABL P210 Fusion Gene Detection Kit
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Shanghai Rightongene Biotechnology Co., Ltd (SHA: 688217), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its BCR-ABL P210 fusion gene detection kit, which uses the fluorescence reverse transcription polymerase chain reaction (RT-PCR) method. The kit is…
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BOE-Backed Genewise Bio Secures RMB 100 Million in Series A Financing for Molecular Diagnostics
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Genewise Bio, a molecular diagnostics company nurtured by BOE Technology Group, has reportedly secured RMB 100 million in a Series A financing round. Tsing Song Capital led the investment round, with additional investments from Wuhe Capital, Aeonmed, and Pinnacles Medtech. Established in 2021, Genewise Bio has developed a comprehensive independent…
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Zylox-Tonbridge Medical Technology Earns NMPA Approval for First Vascular Stapler in China
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Zylox-Tonbridge Medical Technology (HKG: 2190), a leading developer of nerve and peripheral vascular interventional devices based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its proprietary ZYLOX Unicorn vascular stapler, marking the first approval of its kind in China. The…
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Varian Medical Gets China Approval for Fourth-Generation Halcyon Radiotherapy System
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Varian Medical Systems (NYSE: VAR), a US-based leader in cancer treatment technology, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its fourth-generation Halcyon radiotherapy platform. The Halcyon system is a circular rack radiotherapy platform designed to deliver efficient image-guided automated radiation therapy.-…
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Hygea Medical’s Subsidiary Gets Green Light for Innovative Intrahepatic Puncture Instrument in China
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Hygea Medical Technology Co., Ltd, a China-based medical device company, has announced that its subsidiary, Beijing Ailin Medical Technology Co., Ltd, has received marketing approval in China for an innovative intrahepatic puncture instrument designed for use via the jugular vein. The instrument is intended for intrahepatic portal vein puncture to…
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Andon Health’s COVID-19 Trio Test Kit and OTC Antigen Test Win FDA Approval
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Andon Health Co., Ltd (SHE: 002432), a healthcare company based in China, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for two of its COVID-19 testing products. The first is the iHealth COVID-19/Flu A&B Rapid Test Pro, a triple detection point-of-care (POC) kit…
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Jiangxi Rimag Group Sets IPO Price Range for Hong Kong Debut, Aims to Raise Up to USD 2.15 per Share
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Jiangxi Rimag Group Co., Ltd, a leading medical imaging services provider based in China, has set the pricing range for its initial public offering (IPO) on the Hong Kong Stock Exchange. The price band is set between HKD 14.6 and 16.8 per share, which equates to approximately USD 1.87 to…
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Sino Medical Sciences’ Innovative Drug-Coated Stent System Accepted for NMPA Review
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Sino Medical Sciences Technology Inc. (SHA: 688108), a China-based medical technology company, has announced that the National Medical Products Administration (NMPA) has accepted for review its marketing approval filing for a self-expanding intracranial drug-coated stent system. Designed for the treatment of intracranial atherosclerotic stenosis, the product is intended to support…
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Blue Sail Medical Receives NMPA Approval for Disposable Coronary Intravascular Impact Waveguide
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China’s Blue Sail Medical Co., Ltd (SHE: 002382) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its disposable coronary intravascular impact waveguide, SoniCracker CL. This product is designed to be used in conjunction with the company’s proprietary coronary intravascular shock wave therapy…
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Boston Scientific Gets NMPA Approval for Agent DCB, First of Its Kind for Coronary ISR Treatment
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Boston Scientific Corporation (NYSE: BSX), a leading medical device manufacturer in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Agent paclitaxel coated PTCA balloon catheter (AGENT DCB). This product is designed for the treatment of coronary in-stent restenosis (ISR)…
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FDA Alert: Chinese Syringe Maker Jiangsu Shenli Initiates Voluntary Recall
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This week, the US Food and Drug Administration (FDA) provided a status report on its ongoing assessment of quality and performance issues concerning plastic syringes manufactured in China. The update highlighted that Jiangsu Shenli Medical Production Co., Ltd, a Chinese company, has voluntarily initiated a recall to halt the distribution…
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BGI Genomics Delays Market Filing for BRCA1/2 Detection Kit Due to Incomplete Data
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BGI Genomics Co., Ltd (SHE: 300676), a leading genomics company based in China, has announced an unsuccessful market filing for its BRCA1/2 gene mutation detection kit, which utilizes the combined probe anchored polymerization sequencing method. The company cited the failure to complete the required complement and correction of information as…
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Hymson Laser’s Mid Infrared Femtosecond Laser Technology Makes Medical Industry Inroads
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Shenzhen-based Hymson Laser Technology Group Co., Ltd (SHA: 688559) has announced a significant breakthrough with the application of its mid-infrared femtosecond laser technology in healthcare. The company has developed a long wave infrared femtosecond laser (LWIRFS) with a wavelength range exceeding 5 μm, marking a global first in its category.…
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Medtronic’s Advanced Mazor X Spinal Surgery Robot Receives Chinese Market Clearance
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Medtronic (NYSE: MDT), the US-Irish medical technology giant, has announced that it has received approval from Chinese authorities for its fully upgraded Mazor X spinal surgery robot integrated platform. This marks a significant milestone for the company’s advanced surgical solutions in the Chinese market. Initially launched in China in 2021,…
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Chunlizhengda’s Handheld Orthopedic Robot Approved by China’s NMPA
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Beijing Chunlizhengda Medical Instruments Co., Ltd (HKG: 1858, SHA: 688236) has received marketing approval from China’s National Medical Products Administration (NMPA) for its INS 1 handheld orthopedic robot. This development marks a significant step forward in the adoption of domestic medical robotics in China. To date, 17 domestically produced joint…
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Lifetech Scientific’s IBS Stent Demonstrates Non-Inferiority in Phase II Trial
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Lifetech Scientific Corporation (HKG: 1302), a biopharmaceutical company based in China, has announced the completion of the one-year follow-up of its Phase II clinical study for the IBS absorbable drug-eluting coronary stent system. The results were initially published at the EuroPCR 2024. The prospective, multi-center, single-blinded, random-controlled Phase II study,…
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GE HealthCare Partners with Shanghai Pudong for USD 52.5 Million Medical Tech Investment
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GE HealthCare (NASDAQ: GEHC), a leading medical technology firm, has entered into a cooperation intent letter with the Pudong district of Shanghai, committing an investment of RMB 380 million (USD 52.5 million). This strategic partnership will focus on the introduction of new products, construction of new production lines, green factory…
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Vision Medicals Raises Hundreds of Millions in Series D+ Round to Advance Molecular Diagnostics
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Guangdong-based Vision Medicals has reportedly secured hundreds of millions of renminbi in a Series D+ financing round, led by Kequan Investment with participation from Tianxin Fund. The funds raised will be directed towards accelerating the research and development of precision diagnosis products focused on pathogenic molecules. Additionally, the company plans…
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NMPA Accepts Jiangsu Yahong Meditech’s Application for Cervical HSIL Treatment Cevira
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for Cevira (APL-1702) for the treatment of high-grade squamous intraepithelial lesions (HSIL) of the cervix, excluding in…
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Subtle Medical Inc Closes USD 10 Million Series B+ Round to Accelerate Global Expansion
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Subtle Medical Inc, a medical imaging specialist and Stanford University spin-off, has reportedly raised close to USD 10 million in a Series B+ financing round. The financing was backed by investors including Shanghai-based Wenzhou Capital, Fusion Fund, ENVISIONX Capital, Bluerun Ventures, and other strategic partners across the Asia Pacific region.…
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Jiangsu BioPerfectus’ Dengue Detection Kit Gains NMPA Approval for Commercialization
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Jiangsu BioPerfectus Technologies Co., Ltd (SHA: 688399), a leading in vitro diagnostic (IVD) product manufacturer based in China, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its Dengue virus NS1 antigen detection kit, which employs the colloidal gold method. The product…
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MicroPort MedBot’s Toumai Robot Gets EU Green Light for Broad Surgical Applications
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that its Toumai endoscopic surgery robot has received CE qualification from the European Union, allowing the product to be marketed and used for urology, general surgery, thoracic surgery, and gynecological endoscopic surgeries within the EU. The Toumai robot is the…
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MicroPort CardioFlow Medtech’s AltaValve Receives FDA Breakthrough Designation for Mitral Regurgitation Treatment
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MicroPort Scientific Corp (HKG: 0853), a leading medical device company based in China, has announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has received Breakthrough Devices status from the US Food and Drug Administration (FDA) for its AltaValve transcatheter mitral valve replacement device. This product, co-developed with…
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Blue Sail Medical’s New Catheter Receives NMPA Approval for Complex Coronary Lesion Treatment
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China’s Blue Sail Medical Co., Ltd (SHE: 002382) has received marketing approval from the National Medical Products Administration (NMPA) for its new coronary artery balloon dilation catheter, classified as a Category III medical device. This development marks a significant step forward in the treatment of complex coronary artery lesions, including…
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Andon Health’s Triplex Virus Test Kit Receives US FDA Emergency Use Authorization
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Andon Health Co., Ltd (SHE: 002432), a leading healthcare company based in China, has announced that it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its novel triplex test kit, capable of detecting COVID-19, influenza A virus, and influenza B virus. The product…
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Medtronic’s RDN System Symplicity Spyral Earns First-Ever NMPA Approval
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Medtronic (NYSE: MDT), the US-Irish medical device giant, has announced that its Symplicity Spyral renal denervation (RDN) system has become the first of its kind to receive market approval from China’s National Medical Products Administration (NMPA). The company celebrates this milestone, which positions it at the forefront of the RDN…
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Yantai Dongcheng Pharmaceutical’s Radiopharmaceutical 18F-LNC1007 Cleared for Australian Phase I Trial
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that its radioactive diagnostic drug, 18F-LNC1007 injection, has successfully passed a safety review conducted by the US Food and Drug Administration (FDA). This clearance paves the way for the drug to commence a Phase I clinical…
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Wondfo Biotech’s WELLlife Test Kit Receives FDA Nod for Home Use in the US
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Guangzhou Wondfo Biotech Co., Ltd (SHE: 300482), a leading biotechnology company based in China, has announced that it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its WELLlife COVID-19/Influenza A&B Home Test. This triplex test kit, available in an over-the-counter (OTC) version, is…
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United Imaging’s uMR Jupiter 5T Becomes First Ultra-High Frequency MRI System to Gain FDA Approval
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Shanghai-based medical equipment manufacturer United Imaging Healthcare (UIH, SHA: 688271) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its uMR Jupiter 5T magnetic resonance imaging (MRI) system. This product is recognized as the world’s first ultra-high frequency (UHF) system approved for…
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Well Lead Medical’s Stone Removal Sheath Gains Karl Storz as US Sole Agent
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Well Lead Medical Co., Ltd (SHA: 603309), a Guangzhou-based specialist in medical catheters, has entered into a strategic partnership with Karl Storz, a leading endoscopy company based in Germany. Under the agreement, Karl Storz will serve as the exclusive agent in the US for Well Lead’s ClearPetra suction-evacuation ureteral access…
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China’s National Procurement Office Announces Continuous VBP for Joint Prosthetics
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The National High-Value Medical Consumables Joint Procurement Office in China has initiated a new round of continuous volume-based procurement (VBP) for joint prosthetics. All provinces are mandated to participate in procurement alliances, including both public and private medical institutions. The Tianjin Pharmaceutical Procurement Center will handle the daily operations and…
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Mindray Bio-Medical Electronics Reports 15.04% YOY Revenue Growth in 2023 Financial Results
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd (SHE: 300760) has announced its financial results for 2023, with revenues reaching RMB 34.932 billion (USD 4.82 billion), reflecting a robust year-on-year (YOY) growth of 15.04%. Net profits for the medical equipment manufacturer surged to RMB 11.58 billion (USD 1.6 billion), marking an increase…
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MicroPort CardioFlow Medtech’s VitaFlow Liberty Receives CE Mark for European Expansion
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China-based MicroPort Scientific Corp (HKG: 0853), a leading medical device company, announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has secured the CE mark for its VitaFlow Liberty transcatheter aortic valve and its recyclable delivery system. This regulatory approval paves the way for the product’s market entry…
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Jenscare Scientific’s LuX-Valve Fails to Gain Approval from China’s CDME
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Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced that its transcatheter tricuspid valve replacement system, LuX-Valve, did not pass the approval review by China’s Center for Medical Device Evaluation (CDME). The LuX-Valve, which was granted innovative medical device status in China in 2019 and…
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China’s Health Authorities Investigate Alleged Price Manipulation in Pharma Procurement Tenders
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Chinese health regulators are delving into allegations of irregular pricing practices during the national volume-based procurement (VBP) tenders for several pharmaceutical products. A joint statement issued by the National Drug Alliance Procurement Office and the Shanghai Pharmaceutical Centralized Bidding Procurement Management Office cited public complaints regarding the bidding and pricing…
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Guangzhou LBP Earns NMPA Nod for HER2 Detection Reagent to Guide Breast Cancer Treatment
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Guangzhou LBP Medicine Science & Technology Co., Ltd (SHA: 688393), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its HER2 antibody reagent, which is utilized for immunohistochemistry. This new product is designed for the in vitro…
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China’s NMPA Launches 2024 Medical Device Industry Standard Revision Plan
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The National Medical Products Administration (NMPA) has unveiled the “2024 Medical Device Industry Standard Revision Plan Project,” calling for the participation of medical products administration bureaus from key provinces and cities, including Beijing, Tianjin, Liaoning, Shanghai, Jiangsu, Zhejiang, Shandong, Hubei, and Guangdong, as well as Guangzhou city. The National Institutes…
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Shanghai Electric Group and Siemens Healthineers Unveil Ultramarine Series Medical Imaging Devices
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Shanghai Electric Group, a major player in China’s electrical equipment industry, has partnered with Siemens Healthineers, the German medical technology giant, to launch the Ultramarine series of medical imaging products. The new lineup features three domestically produced medical imaging devices: the Ultramarine 1.5T MRI, Ultramarine 128 CT, and Ultramarine 32…
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Roche and Eli Lilly’s Elecsys pTau217 Blood Test Earns FDA Breakthrough Designation for Alzheimer’s Detection
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The U.S. Food and Drug Administration (FDA) has granted a breakthrough device designation for Elecsys pTau217, a blood test co-developed by Roche (SWX: ROG) and Eli Lilly (NYSE: LLY), aimed at detecting amyloid pathology, a hallmark of Alzheimer’s disease. This designation is significant in the context of the growing global…
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Bayer Partners with Hologic to Develop Contrast-Enhanced Mammography Solution for Breast Cancer Diagnosis
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Bayer (ETR: BAYN), a multinational pharmaceutical and life sciences company headquartered in Germany, has announced a strategic partnership with Hologic (NASDAQ: HOLX), a leading women’s health specialist. The collaboration aims to develop a contrast-enhanced mammography (CEM) solution that serves as a cost-effective adjunct to traditional mammography for breast cancer diagnosis.…
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LargeV Instrument’s IPO on STAR Board Halted Following Filing and Sponsorship Withdrawal
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The initial public offering (IPO) of LargeV Instrument Corp., Ltd to the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR) has been suspended for review, following the withdrawal of the filing and sponsorship. The Beijing-based company, which specializes in the research and development (R&D), manufacturing, and marketing of medical cone-shaped beam…
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Aptar Pharma Secures NMPA Approval for Airless Drug Delivery System in Chin
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Aptar Pharma, a U.S.-based company, announced that its Mezzo+ CS (China Support) Airless dispensing solution has received market approval in China. This innovative system is designed for dermal drug delivery and will be utilized for Sinomune Pharmaceutical’s metronidazole gel, which has been approved by the National Medical Products Administration (NMPA)…
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Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
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Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
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Transcenta Holdings Ltd Collaborates with Agilent Technologies on Companion Diagnostic for Osemitamab
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced a strategic agreement with Agilent Technologies to co-develop Claudin18.2 companion diagnostic reagents, marking a significant step in the global development of osemitamab combined with nivolumab plus chemotherapy for first-line treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ)…
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Adicon Launches GuardantOMNI Test to Advance Tumor Therapy Development in China
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Adicon Holdings Ltd (HKG: 9860), a China-based independent clinic laboratory service provider, has announced the launch of its GuardantOMNI test, a 500-gene panel based on blood sample detection, alongside its previously introduced liquid biopsy product, Guardant360. This initiative aims to enhance the development of tumor-targeted drugs and immunotherapies in clinical…
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Sino Medical Secures Approval for Innovative Drug-Coated Stent System Targeting Intracranial Stenosis
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Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced that it has received marketing approval from the Center for Medical Device Evaluation for its innovative self-expanding intracranial drug-coated stent system. This approval was granted through the special review channel, recognizing the device’s potential to treat intracranial atherosclerotic…
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Huihe Healthcare’s Vispearl Microsphere Earns Marketing Approval in China for Innovative Cancer Treatment
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Shanghai-based Huihe Healthcare, a developer of interventional medical devices for structural heart diseases, has secured marketing approval in China for its innovative Vispearl drug-loaded microsphere product. This product is designed for use in the embolization treatment of malignant tumors within vascular-rich parenchymal organs and is recognized as the first of…
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Johnson & Johnson MedTech Launches CPX4 PLUS Tissue Expander for Breast Reconstruction in China
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Johnson & Johnson (J&J, NYSE: JNJ) MedTech, a leading healthcare conglomerate in the US, has announced the official market launch of its CPX4 PLUS tissue expander in China. This marks the introduction of the first breast tissue-specific expander in the country, designed to benefit a greater number of breast cancer…
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Chinese Scientists Discover Breakthrough Biodegradable Piezoelectric Material for Medical Implants
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A team of Chinese scientists from Southeast University in Nanjing has made significant strides in the development of advanced materials for medical implants. Their research focuses on creating a transient implantable piezoelectric material that addresses the issues of biodegradability and brittleness commonly found in current options. These piezoelectric materials are…
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Abiomed Recalls Over 66,000 Impella Heart Pumps Due to Serious Injury Risk, FDA Classifies as Class I Event
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Johnson & Johnson (J&J, NYSE: JNJ), already embroiled in lawsuits over alleged cancer risks associated with its talcum powder products, faces a new product safety scandal. The company’s medical device subsidiary, Abiomed, has initiated a recall of over 66,000 Impella left-sided heart pumps due to a risk of heart perforation…
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AstraZeneca’s Tralokinumab Trial Data Spurs Development of Brainomix’s e-Lung Software
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AstraZeneca (AZ; NASDAQ: AZN) has reported data from a Phase II trial for its idiopathic pulmonary fibrosis (IPF) candidate, tralokinumab, which has contributed to the development of Brainomix’s e-Lung software. This AI-enabled tool, announced by the UK medtech company this week, is designed to identify patients at risk of decline…
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Tianjin University Team Develops Self-Sustaining Na-O2 Battery for Implantable Devices
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Researchers at China’s Tianjin University of Technology have made a groundbreaking advancement with the development of an implantable and bio-compatible Na-O2 battery. This innovation could significantly transform the landscape of implantable medical devices by potentially eliminating the need for frequent invasive surgeries to replace depleted batteries in devices like pacemakers…
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Acotec Scientific Receives NMPA Approval for Innovative Cardiovascular Devices
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Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for two of its innovative products: the coronary hypertension balloon dilation catheter wing extension and the microcatheter Vericor-RS. The coronary…
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Zylox-Tonbridge Secures NMPA Approval for Advanced Flow Diverter Targeting Intracranial Aneurysms
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Zylox-Tonbridge Medical Technology (HKG: 2190), a China-based developer of nerve and peripheral vascular interventional devices, has secured marketing approval from the National Medical Products Administration (NMPA) for its flow diverter (FD). This device represents a significant advancement in the treatment of intracranial aneurysms, particularly large and giant aneurysms. Notably, this…
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Jenscare Scientific Completes Enrollment in Clinical Study for Mitral Valve Repair System
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer headquartered in Ningbo, has announced the successful completion of patient enrollment in a confirmatory study for its flagship product, the JensClip transcatheter mitral valve repair and clamping system. The system is designed to address severe mitral regurgitation,…
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Intuitive Surgical’s Ion Robotic System Gains Regulatory Approval in China
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Intuitive Surgical (NASDAQ: ISRG), a leading medical robotics firm based in the US, has announced that it has received regulatory approval in China for its Ion surgical robot system. Initially approved in the US in 2019, the Ion system is a robotic-assisted, catheter-based platform designed for minimally invasive biopsy procedures…
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Sino Medical Sciences Secures South Korean Approvals for Three Cardiovascular Devices
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical device company, has announced that it has received marketing approvals from South Korean regulatory authorities for three of its cardiovascular products: the HT Supreme drug-eluting stent, the NC ROCKSTAR non-compliant balloon dilation catheter, and the SC HONKYTONK coronary balloon…
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Sino Medical Sciences Receives Hong Kong Approval for HT Supreme Drug-Eluting Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that it has received marketing approval in Hong Kong for its HT Supreme drug-eluting stent system. The system is now approved for use in symptomatic heart disease patients to improve the coronary artery lumen diameter caused…
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ARSMO Plastic Aesthetic Hospital Introduces Liquid PCL Implant GOURI in Hainan
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ARSMO Plastic Aesthetic Hospital Holding Co., Ltd. has announced the inaugural application of GOURI, a fully liquid polycaprolactone (PCL) based dermal filler, in its Hainan-based unit. GOURI is a renewable material that utilizes CESABP technology, allowing it to be fully liquid and to decompose gradually, thereby promoting the natural regeneration…
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Jenscare Scientific Achieves Milestone with First LuX-Valve Plus Implantation in Brazil
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer headquartered in Ningbo, China, has announced the successful completion of the first clinical implantation surgery using its transjugular tricuspid valve replacement product, LuX-Valve Plus, in Brazil. This milestone marks a significant advancement for the company in the…
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MicroPort CardioFlow Forecasts 31%-36% YOY Sales Growth for 2023 Driven by TAVI Product Expansion
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off from China-based MicroPort Scientific Corp (HKG: 0853), has announced a forecast for its 2023 financial performance along with key business updates. The company anticipates generating sales within the range of RMB 330 million to RMB 340 million for the year, reflecting…
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Rossum Robot’s Intelligent Surgical Robot for Trauma and Spinal Surgery Clears NMPA Approval
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Rossum Robot, a Beijing-based developer of orthopedic surgical robots specializing in pelvic fracture procedures, has received marketing approval from the National Medical Products Administration (NMPA) for its intelligent small surgical robot designed for trauma and spinal surgery applications. This regulatory clearance marks a significant advancement for Rossum Robot as it…
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Zylox-Tonbridge Receives UAE Approval for Five Medical Devices, Expands Middle East Presence
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Zylox-Tonbridge (HKG: 2190), a Chinese specialist in medical devices, has announced a series of product marketing approvals from the United Arab Emirates (UAE) Ministry of Health and Prevention. The company received approval for a total of five products, including the ZENFluxion Drug-coated PTA Balloon Catheter, ZENFlow HP PTA Balloon Catheter,…
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Boao Yiling Life Care Center Launches Innovative Dental Technologies Under Pilot Medical Policy
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Boao Yiling Life Care Center has successfully completed the inaugural use of a dental comprehensive treatment table and a dental healing cap (MED) licensed from Germany’s Sirona Dental Systems GmbH and Israel’s Magdent Ltd. This milestone was achieved under the “first pilot, first trial” special medical policy in the Boao…
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Peijia Medical’s Taurus Atlas Pro Balloon Dilation Catheter Approved by NMPA for Pulmonary Valve Procedures
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Peijia Medical Ltd (HKG: 9996) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its second-generation balloon dilation catheter, Taurus Atlas Pro. This non-compliant balloon is designed for percutaneous transluminal valvuloplasty of the pulmonary valve. The Taurus Atlas Pro balloon dilation catheter is…
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Acotec Scientific’s Peridge Catheter Receives NMPA Nod for Hemodialysis Lesion Treatment
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Acotec Scientific Holdings Ltd (HKG: 6669), a China-based medical device company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its innovative peripheral scoring balloon dilation catheter, Peridge. This device is designed for the treatment of occlusive lesions in autologous or synthetic arteriovenous…
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Shanghai’s Reunion Biotech Secures Series B Funding to Advance Hydrogel Products
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Reunion Biotech, a Shanghai-based medical hydrogel manufacturer, has reportedly secured nearly RMB 100 million (USD 14 million) in a Series B financing round. The funding was led by Dingxin Capital, with existing investors Qiming Venture Partners and Conson Financial Holdings contributing to the oversubscribed round. The proceeds will be allocated…
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Establishment Labs Launches Motiva Breast Implants in China
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Establishment Labs Holdings Inc., (NASDAQ: ESTA), a US-based medical technology company specializing in women’s health, has announced the official market launch of its Motiva brand breast implants in China. The company’s product line includes the Motiva Flora tissue expander, which is designed to enhance the outcomes of breast reconstruction post-breast…
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Zylox-Tonbridge Medical Technology Secures NMPA Nod for Innovative Iliac Vein Stent System
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Zylox-Tonbridge Medical Technology (HKG: 2190), a leading developer of nerve and peripheral vascular interventional devices based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its ZYLOX Penguin iliac vein stent system. This innovative product is designed for the treatment of…
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Jiangsu Wuzhong Pharmaceutical’s Aesthetics Subsidiary Wins Approval for Facial Filler in China
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Jiangsu Wuzhong Pharmaceutical Group Corp., (SHA: 600200), a prominent player in the Chinese pharmaceutical industry, has announced that its medical aesthetics subsidiary’s polylactic acid facial filler, AestheFill, has received marketing approval in China. The product is slated to become available in mainland China in the first half of 2024. AestheFill,…
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Lepu Medical Technology Gains NMPA Approval for Innovative Coronary Device
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading Chinese provider of cardiovascular disease solutions, has received marketing approval from the National Medical Products Administration (NMPA) for its self-developed coronary mastoid balloon dilation catheter. The device, classified as a Category III medical device, is indicated for balloon dilation in…
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Abbott Initiates Clinical Study for Volt PFA System in Australia for Cardiac Arrhythmias
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Abbott (NYSE: ABT) has announced that the first patients have been treated with its Volt pulsed field ablation (PFA) system as part of a clinical study in Australia. The study is designed to evaluate the safety and effectiveness of the device in treating common cardiac arrhythmias such as atrial fibrillation…
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Ultrasound Biotechnology Earns FDA Nod for Disposable Endoscopic Ultrasound Probes
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Ultrasound Biotechnology, the Shanghai-based wholly owned subsidiary of US firm Ultrasound Wondering, Inc., has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its “Endoscopic ultrasound diagnostic equipment and disposable sterile endoscopic ultrasound probes” product. This marks a significant milestone as the company…
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Lepu Medical Secures NMPA Approval for Innovative Coronary Intravascular Impact Waveguide Tube
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a China-based provider of cardiovascular disease solutions, has received marketing approval from the National Medical Products Administration (NMPA) for its proprietary disposable coronary intravascular impact waveguide tube. This Category III device is now authorized for use in the pre-treatment and balloon dilation…
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Sino Medical Sciences’ HT Supreme Drug-Eluting Stent System Gains Market Approval in Bangladesh
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Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical device company, has announced that it has received market approval in Bangladesh for its HT Supreme drug-eluting stent system. The system is designed to improve the diameter of the coronary artery lumen in patients with symptomatic heart disease caused by…
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AbbVie Launches Continuous Infusion Therapy for Advanced Parkinson’s Disease in EU
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AbbVie (NYSE: ABBV) has announced the launch of its dopamine replacement therapy, Produodopa (foslevodopa + foscarbidopa), in the European Union (EU) for the treatment of advanced Parkinson’s disease (PD). The therapy is indicated for patients experiencing severe motor fluctuations, hyperkinesia, or dyskinesia, and when other treatments fail to adequately control…
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Sinocare Partners with Illumina to Localize iScan Chip Scanners for Precision Health Applications
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Sinocare Inc. (SHE: 300298), a China-based company, has entered into a partnership agreement with U.S. giant Illumina (NASDAQ: ILMN) to localize the iScan high-end chip scanners. This collaboration aims to harness their technological strengths and resources to enhance the application of genomics in precision health management, with a particular focus…
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ShuWen Biotech’s MammaTyper Diagnostic Kit Receives NMPA Approval for Breast Cancer Molecular Classification
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ShuWen Biotech Co., Ltd, a biopharmaceutical company based in Zhejiang, has announced that its MammaTyper diagnostic kit has received market approval from the National Medical Products Administration (NMPA). The kit is intended for use in cases where immunohistochemistry (IHC) results are indeterminate or unsatisfactory, or when the IHC outcome significantly…
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MicroPort CardioFlow Medtech’s AnchorMan System Receives NMPA Approval as First Semi-Closed LAA Occluder in China
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MicroPort Scientific Corp (HKG: 0853), a leading medical device company based in China, has announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has received marketing approval from the National Medical Products Administration (NMPA) for La Ronda’s AnchorMan left atrial appendage occluder system. This marks the first semi-closed…
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P-Cure Initiates Construction of Affordable Proton Therapy Center in China’s Shandong Province
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P-Cure, an Israeli company specializing in proton therapy, has commenced construction on a proton therapy center in Taian city, Shandong province, China, according to a report by the South China Morning Post. The development is being carried out by P-Cure’s Chinese subsidiary, SIHA, with the goal of providing precision cancer…
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Sino Medical Secures Approvals for Key Coronary Devices in Taiwan, India, and Uzbekistan
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Sino Medical Sciences Technology Inc. (SHA: 688108), a China-based medical device company, has announced that it has received market approvals in Taiwan, India, and Uzbekistan for its SC HONKYTONK coronary artery balloon dilation catheter, NC Rockstar non-compliant coronary artery balloon dilation catheter, and HT Supreme drug-eluting stent system. The NC…
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Cryofocus Biotechnology Secures NMPA Approval for Cryotherapy Equipmen
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Shanghai-based Cryofocus Biotechnology Co., Ltd. (HKG: 6922) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its cryotherapy equipment, which supports its innovative frozen adhesion treatment system. The cryotherapy equipment comprises a main unit, a foot switch, and an exhaust pipe, and is…
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NMPA Approves Pulnovo Medical’s Novel Catheter for Treating Pulmonary Arterial Hypertension
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The National Medical Products Administration (NMPA) has granted marketing approval for Pulnovo Medical’s disposable circular pulmonary artery radiofrequency ablation catheter, marking it as a novel product in the medical device landscape. This innovative catheter employs a puncture intervention technique to access the bloodstream, targeting pulmonary arterial hypertension by disrupting the…
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Fresenius Medical Care Expands Dialysis Solutions in China with 6008 CARESystem Launch
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Fresenius Medical Care AG has announced the official launch of its 6008 CARESystem hemodialysis filtration system in China, marking a significant advancement in the treatment options for patients with renal failure in the country. The 6008 CARESystem is comprised of a 6008 blood dialysis device and a complementary 6008 CARESet…
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Beijing Balance Medical Secures NMPA Approval for Innovative Mitral Valve Annuloplasty Ring
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198), a Chinese medical device company, has received market approval from the National Medical Products Administration (NMPA) for its proprietary mitral valve annuloplasty ring product. This development marks a significant milestone for the company, which aims to provide advanced cardiac solutions to patients.…
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Zylox-Tonbridge Completes Patient Enrollment for ZENFLEX Study in Germany
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Zylox-Tonbridge Medical Technology (HKG: 2190), a China-based developer of nerve and peripheral vascular interventional devices, has announced the completion of patient enrollment in a multi-center clinical study for its ZENFLEX peripheral vascular stent system in Germany. The study has reached its target of 100 patients. This prospective, multi-center, single-arm study…
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BGI Genomics Receives NMPA Approval for Innovative Colorectal Cancer Detection Kit
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BGI Genomics Co., Ltd. (SHE: 300676), a leading genomics firm based in China, has announced the approval of its medical device license from the National Medical Products Administration (NMPA) for a novel gene methylation detection kit. The kit employs fluorescence PCR technology to assess the combined methylation status of the…
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China Releases Emergency Use Rules for Medical Devices Amid Public Health Emergencies
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The National Medical Products Administration (NMPA), National Health Commission (NHC), and Chinese Center for Disease Control and Prevention (CDC) have jointly issued the “Medical Device Emergency Use Management Rules (trial),” which are effective immediately. These rules govern the emergency use of medical devices within a specified scope and period for…
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MicroPort MedBot’s R-ONE Vascular Intervention Robot Approved by China’s NMPA
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its R-ONE vascular intervention surgical robot. The robot was introduced by Cathbot, a joint venture between MicroPort and French firm Robocath S.A.S in China. R-ONE, a…
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Sino Medical Sciences Secures Market Approvals in Hong Kong, China, and Malaysia for Medical Devices
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approvals for two of its medical devices in Hong Kong, China, and Malaysia. The NC Rockstar non compliant coronary artery balloon dilation catheter has been approved in Hong Kong and China, while the HT Supreme drug eluting stent…
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Cryofocus Biotechnology Receives NMPA Approval for Complete Cardiac Cryoablation System
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Cryofocus Biotechnology Co., Ltd (HKG: 6922), a Shanghai-based specialist in cryoablation treatment, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for all components of its cardiac cryoablation system. The approvals include the cryoablation equipment, balloon type cryoablation catheter (previously known as the atrial…
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Zylox-Tonbridge Medical Technology’s ZENFLOW T18 Receives NMPA Marketing Approval
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Zylox-Tonbridge Medical Technology (HKG: 2190), a developer of nerve and peripheral vascular interventional devices based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed ZENFLOW T18 peripheral balloon dilation catheter. The ZENFLOW T18 is a conical balloon designed…
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AK Medical Secures NMPA Approval for Advanced 3D-Printed Hip Prosthesis Component
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China-based AK Medical Holdings Ltd (HKG: 1789) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Acetabular Component of Hip Prosthesis, classified as a Class III medical device. This innovative product is a 3D-printed titanium alloy orthopedic implant. AK Medical first gained…
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Sinocare Inc’s Blood Glucose Monitoring System Earns US FDA Approval
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Sinocare Inc (SHE: 300298), a Chinese medical device company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its TRUNESS/ TRUNESS AIR blood glucose monitoring system product. The TRUNESS blood glucose monitoring system includes the TRUNESS blood glucose meter and corresponding test…
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Sino Medical Secures Market Approval in Taiwan for NC Rockstar Coronary Catheter
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Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that its NC Rockstar non-compliant coronary artery balloon dilation catheter has received market approval in Taiwan, China. This innovative device, which includes a TIP head, balloon protective sheath, balloon, and inner tube, is designed for balloon catheter dilation of autologous coronary…
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Valgen Secures NMPA Approval for China’s First Transcatheter Mitral Valve Clamp System
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Hangzhou-based Valgen Holding Corporation has received market approval from the National Medical Products Administration (NMPA) for its innovative DragonFly transcatheter mitral valve clamp system, marking it as the first of its kind in China. The DragonFly system is designed for use in transcatheter mitral valve edge-to-edge repair (TEER) procedures and…
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FDA Investigates Safety of China-Made Plastic Syringes Due to Quality Concerns
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The US Food and Drug Administration (FDA) has issued a warning that it is investigating the safety of plastic syringes manufactured in China, which are used for injecting or withdrawing fluids from patients. The notice is a broad warning about potential leaks, breakages, and other issues with all China-made syringes,…
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Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter
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Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance. The…
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AK Medical Holdings Receives NMPA Approval for Hip Surgery Navigation System iBot
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AK Medical Holdings Ltd (HKG: 1789), a Chinese medical technology company, has announced that it has received Category III medical device approval from the National Medical Products Administration (NMPA) for its iBot, a navigation and positioning system designed for hip joint surgery. The iBot system, which includes a robotic arm,…
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Jenscare Reports Positive One-Year Outcomes for LuX-Valve in Tricuspid Valve Replacement Study
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Jenscare Scientific Co., Ltd. (HKG: 9877), a Ningbo-based manufacturer of devices for structural heart disease, has released promising one-year results from a confirmatory study of its transcatheter tricuspid valve replacement system, LuX-Valve. The prospective, multi-center, single-arm study aimed to evaluate the safety and efficacy of the LuX-Valve in patients suffering…
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Yantai Dongcheng Pharmaceutical Gets Green Light for Prostate Cancer Diagnostic Drug Trial
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that it has received ethical approval from Beijing Hospital to conduct a Phase III clinical study. The study will assess the diagnostic efficacy of a radionuclide candidate, intended for use with positron emission tomography (PET) imaging,…
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Gilead Announces Low-Carbon Bronchodilator Study for H1 2024
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Gilead Sciences Inc. (NASDAQ: GILD) has announced plans for a Phase III study in the first half of 2024 for a new iteration of its bronchodilator Ventolin (salbutamol). This version utilizes a low-carbon propellant, which could potentially reduce the greenhouse gas emissions from the associated metered dose inhaler (MDI) by…
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AstraZeneca Launches Evinova to Enhance Global Clinical Development with Digital Health Solutions
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UK-based AstraZeneca (AZ; NASDAQ: AZN) has launched Evinova, a digital health solutions provider, with the aim of supporting global clinical development. Evinova offers AI-enabled technologies and services to clinical trial (CT) sponsors, clinical research organizations (CROs), CT site care teams, and patients. The new business unit will initially focus on…
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Beijing Balance Medical Technology’s Transcatheter Aortic Valve System Accepted for NMPA Review
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China’s Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for a transcatheter aortic valve system for review. Product Features and Clinical ApplicationsThe product is designed for patients with severe aortic valve stenosis who are at…
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Sino Medical Sciences Technology’s HT Supreme Stent Gains Brazilian Market Approval
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Sino Medical Sciences Technology Inc., (SHA: 688108) a leading China-based medical device company, has announced that its HT Supreme drug-eluting stent system has received market approval in Brazil. This system is designed to improve the diameter of the coronary artery lumen in patients suffering from symptomatic heart disease caused by…
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Sansure Biotech Secures CE IVDR Certifications for Chemiluminescence Analyzers in the EU
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China-based molecular diagnostics specialist, Sansure Biotech Inc., (SHA: 688289), has announced that it has received CE IVDR certifications in the European Union for two of its fully automatic chemiluminescence immunoassay analyzer products. This regulatory milestone marks a significant step forward for the company in expanding its presence in the EU…
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Sino Medical Sciences Technology Secures EU MDR Approval for HT Supreme Drug-Eluting Stent System
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced that it has received Medical Device Regulation (MDR) approval in the European Union for its HT Supreme drug-eluting stent system. Features of the HT Supreme Drug-Coated Coronary Artery Stent SystemThe HT Supreme drug-coated coronary artery stent system is a combination…
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Establishment Labs Receives NMPA Approval for Motiva Silicone Gel-Filled Breast Implants
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US-based medical technology company Establishment Labs Holdings Inc., (NASDAQ: ESTA) has announced that it has received product approval from China’s National Medical Products Administration (NMPA) for its Motiva silicone gel-filled breast implants. This marks the company’s first approval in China, the world’s second-largest market for breast implants. Originally approved in…
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Lifetech Scientific Corporation Receives NMPA Approval for Peripheral Thrombus Suction Catheter
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Lifetech Scientific Corporation (HKG: 1302), a China-based medical device company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its innovative peripheral thrombus suction catheter. This device is designed for the removal of thrombi from the peripheral arterial and venous vascular systems, offering…
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Fosun Pharmaceutical and Insightec Collaborate on Non-Invasive Brain Treatment Technology
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced a strategic partnership with Israel-based medical device company Insightec Ltd, a leader in magnetic resonance (MR)-guided Focused Ultrasound equipment. This partnership aims to apply Insightec’s advanced Focused Ultrasound brain therapy technology for the treatment of idiopathic tremors and Parkinson’s disease…
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Sun Yat-sen Memorial Hospital Partners with Siemens Healthineers on Metaverse Visualization Surgery
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China’s Sun Yat-sen Memorial Hospital, affiliated with Sun Yat-sen University, has entered into a strategic partnership with Germany-based life sciences giant Siemens Healthineers AG (ETR: SHL) at the 6th China International Import Expo (CIIE) in Shanghai. The collaboration focuses on the science research, application, and translation of metaverse visualization surgery,…
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Intuitive Surgical-Fosun Medical Launches Da Vinci Xi Surgical Robot at CIIE
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Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and US-based Intuitive Surgical Inc., has announced the official launch of the Da Vinci Xi surgical robot at the 6th China International Import Expo (CIIE) in Shanghai. The Da Vinci Xi…
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Amoy Diagnostics Receives NMPA Approval for MSI Detection Kit as Companion Diagnostic for Immunotherapy
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in the Chinese diagnostics industry, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its human microsatellite instability (MSI) detection kit. This kit, which utilizes fluorescent PCR capillary electrophoresis,…
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Sino Medical Sciences Technology Secures TFDA Approval for HT Supreme Drug-Eluting Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for its HT Supreme drug-eluting stent system. This significant milestone marks the company’s expansion into the Taiwan market with a cutting-edge drug-device…
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Siyi Intelligence Secures Approval for Innovative Rehabilitation Robots in China
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Shanghai-based Siyi Intelligence, a developer of soft rehabilitation robots, has announced that it has received marketing approvals from the National Medical Products Administration (NMPA) for two of its groundbreaking rehabilitation robots: the “Yisheng Upper Limb Intelligent Rehabilitation Training and Evaluation System” and the “Yisheng Brain Computer Interface (BCI) Rehabilitation Training…
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Jenscare Scientific’s Ken Valve Enters NMPA Priority Review for Aortic Valve System
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer based in Ningbo, has announced that its regulatory filing for the transcatheter artificial aortic valve system, Ken Valve, has been accepted into the priority review process by the National Medical Products Administration (NMPA). This marks a significant…
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MicroPort CardioFlow Medtech Completes Clinical Implantations of Second-Generation TAVI Device
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of China-based MicroPort Scientific Corp (HKG: 0853), has announced the successful completion of seven clinical implantations of its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty. The surgeries were performed in Denmark and Ireland, with all patients recovering well post-operation.…
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MicroPort MedBot’s Toumai Robot Gains NMPA Approval for Endoscopic Surgery
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252), a leading medical robotics company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Toumai endoscopic surgery robot. This approval allows the robot to be used across multiple departments for a variety of surgical…
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Blue Sail Medical Enrolls First Patient in Study for Rapamycin-Coated Balloon Catheter
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China’s Blue Sail Medical Co., Ltd (SHE: 002382) has announced a significant milestone with the enrollment of the first patient in a prospective, multi-center, randomized controlled clinical study. The study is designed to assess the efficacy and safety of Blue Sail Medical’s rapamycin-coated balloon dilation catheter for arteriovenous fistula in…
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Jenscare’s LuX-Valve Plus Completes Compassionate Use Cases in Asia-Pacific
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading device maker specializing in structural heart disease solutions, has announced the successful completion of a series of paid compassionate use cases for its innovative transjugular tricuspid valve replacement product, LuX-Valve Plus, across multiple hospitals in the Asia-Pacific region. Clinical Success and Industry…
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Lepu Medical Gains NMPA Approval for Semi-Automatic External Defibrillator
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its in-house developed semi-automatic external defibrillator. This approval marks a significant milestone in expanding Lepu’s portfolio of life-saving medical devices. The…
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MicroPort CardioFlow Medtech’s Third-Generation TAVI Product Achieves Initial Clinical Success
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off from China-based MicroPort Scientific Corp (HKG: 0853), has announced the successful completion of the first two clinical applications of its third-generation transcatheter aortic valve implantation (TAVI) product. This advanced medical device features a recyclable and controllable bend delivery system, which was…
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Nanjing Geneseeq’s NSCLC TMB Detection Kit Approved by NMPA
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China-based Nanjing Geneseeq Medical Device and Diagnostic Inc. has announced that its tissue tumor mutation burden (TMB) detection kit, utilizing a reversible end termination sequencing method, has received marketing approval from the National Medical Products Administration (NMPA). This marks the kit as the 231st novel medical device approved in China.…
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Jiangsu BioPerfectus Secures NMPA Approval for Norovirus Nucleic Acid Detection Kit
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China-based Jiangsu BioPerfectus Technologies Co., Ltd (SHA: 688399), a leading manufacturer of in vitro diagnostic (IVD) products, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its Norovirus nucleic acid detection kit, utilizing the fluorescence PCR method. Innovative Detection of Norovirus The…
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Cochlear’s Artificial Cochlear Sound Processor Gains NMPA Approval for Marketing in China
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Australia-based Cochlear has received marketing approval from the National Medical Products Administration (NMPA) for its artificial cochlear sound processor, as announced by the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration. This innovative product is designed to convert received sounds and transmit electrical stimulation to the auditory nerve through…
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MicroPort Secures Market Approvals for ULYS ICDs and INVICTA Leads in Japan
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Shanghai-based MicroPort Scientific Corp. (HKG: 0853) has announced that its France-based subsidiary, MicroPort Cardiac Rhythm Management Limited (MicroPort CRM), has received market approvals for its ULYS implantable cardioverter defibrillators (ICDs) and INVICTA defibrillation electrode leads in Japan. This milestone marks a significant expansion for MicroPort in the Japanese medical device…
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Med Vision’s Sleep Disorder Software Receives Category II Approval in China
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Hangzhou-based Med Vision, a provider of virtual reality (VR)-enabled digital therapeutics (DTx) solutions, has reportedly received a Category II medical device approval in China for its sleep disorder assisted treatment software. This marks a significant milestone as it is the first VR-based sleep disorder device to be approved both in…
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Sino Medical Sciences’ HT Supreme Stent System Included in French Reimbursement List
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading medical device company based in China, announced that its HT Supreme drug-eluting stent system has been included in the reimbursement drug list (RDL) in France, effective as of October 4, 2023. This inclusion marks a significant milestone for the company’s efforts…
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Cardinal Health Acquires MedAlliance for $1.135 Billion to Enhance Vascular Intervention Portfolio
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US-based Cardinal Health (NYSE: CAH) has announced the acquisition of Swiss firm MedAlliance for a total consideration of USD 1.135 billion. This transaction includes a USD 35 million investment made in 2022, a USD 200 million upfront payment in 2023, and additional regulatory milestone payments totaling USD 125 million, along…
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Neusoft Medical’s NeuRT Aurora Receives NMPA Approval for Advanced Radiotherapy Platform
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Neusoft Medical Systems Co., Ltd, a leading player in the medical technology sector, has announced that its radiotherapy unit, Neusoft Ruizhi Radiotherapy Technology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for the high-end medical linear accelerator, NeuRT Aurora intelligent radiotherapy platform. This approval marks…
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CStone Pharmaceuticals’ PDGFRA Mutation Detection Kit Receives NMPA Approval
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its “Human PDGFRA Gene D842V Mutation Detection Kit”. This companion diagnostic (CDx) kit, co-developed with Beijing-based Genetron Holdings Ltd (Nasdaq: GTH), is used for the detection…
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Sino Medical Sciences Receives Turkish Approval for HT Supreme Drug-Eluting Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical device company, has announced that it has received market approval for its HT Supreme drug-eluting stent system from the Ministry of Health in Turkey. This approval marks a significant expansion of the product’s reach and is set to benefit…
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CIRC Unveils FuZhi 1.0 Smart Nuclear Medicine System at Chinese Medical Association Meeting
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China Isotope & Radiation Corporation (CIRC; HKG: 1763) has announced the launch of its innovative FuZhi 1.0 smart nuclear medicine system at the 2023 annual meeting of the Nuclear Medicine Branch of the Chinese Medical Association. This comprehensive system, which includes modules for smart patient care, smart nuclear drug management,…
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Acotec Scientific Holdings Receives Japanese Marketing Approval for Peripheral Support Catheter Vericor
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Acotec Scientific Holdings Ltd (HKG: 6669), a China-based medical device company, has announced that it has received marketing approval from the Ministry of Health, Labour and Welfare of Japan for its peripheral support catheter, Vericor. This approval allows the product to be used in conjunction with a guide wire to…
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Sansure Biotech Secures CE Mark for 60 Molecular Diagnostic Products, Including Procalcitonin Assay Kit
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Sansure Biotech Inc., a leading molecular diagnostics specialist based in China (SHA: 688289), has announced that it has received CE marks for 60 of its products, including a procalcitonin assay kit that utilizes chemiluminescent immunoassay technology. This significant milestone underscores the company’s commitment to expanding its global footprint and enhancing…
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Jiangsu Yahong’s Cevira Meets Primary Endpoint in Phase III Cervical HSIL Study
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, has announced that its Phase III clinical study for Cevira (APL-1702) in high-grade squamous intraepithelial lesions (HSIL) of the cervix has successfully reached its primary endpoint. Study Design and ResultsThe global, multi-center Phase III study was…
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MicroPort MedBot’s SkyWalker Robot Approved for Orthopedic Surgery by NMPA
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its innovative navigation and positioning system, the SkyWalker hip and knee joint replacement surgery robot. This marks the first approval of an in-house developed mechanical arm…
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AcornMed Receives FDA Breakthrough Device Designation for Urothelial Carcinoma Liquid Biopsy
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Beijing-based tumor precision medicine specialist, AcornMed, has been granted Breakthrough Device Designation (BDD) by the US FDA for its early screening liquid biopsy product, AcornMed utLIFE-UC, designed for detecting urothelial carcinoma. Innovative Liquid Biopsy Technology for Urothelial Carcinoma DetectionThe AcornMed utLIFE-UC product leverages the company’s proprietary database and algorithms to…
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Tuodao Medical’s Percutaneous Puncture Surgery Robot NP100 Approved in China
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China-based surgical robot developer Tuodao Medical Technology Co., Ltd has received marketing approval for its percutaneous puncture surgery robot, known as the puncture surgery navigation and positioning system NP100. This approval marks a significant advancement in the field of surgical robotics within the country. Puncture Surgery and Its ChallengesPuncture surgery…
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Jenscare Scientific’s Tricuspid Valve Replacement System Joins FDA’s TAP Program
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Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced that its in-house developed transcatheter tricuspid valve replacement system product has been included in the Total Product Life Cycle Advisory Program (TAP) of the US FDA. The program’s objective is to ensure that US patients have…
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Genesis MedTech Receives Chinese Market Approval for Antibacterial Absorbable Sutures
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Singapore-based medical device company Genesis MedTech has announced that it has received market approval in China for its absorbable sutures with antibacterial protection. This milestone marks the company as the first domestic brand to successfully develop such a product, enhancing its position in the medical device market. Innovation in Surgical…
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Huadong Medicine’s Subsidiary Viora Ltd’s V20 Accepted for NMPA Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted a Category III market filing for its wholly owned subsidiary Viora Ltd’s V20 optical radiofrequency therapy instrument. This development marks a significant step forward for the company’s entry into the Chinese medical…
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Burning Rock’s CanCatch MRD Product Shows Superiority in Postoperative NSCLC Monitoring
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China-based medtech firm Burning Rock Ltd (NASDAQ: BNR) has revealed positive findings from a five-year clinical trial of its liquid assay-based personalized minimal residual disease (MRD) product, CanCatch (PROPHET panel; Patient-specific pROgnostic and Potential tHErapeutic marker Tracking). The results, published in Cancer Cell under the title “Individualized tumor-informed circulating tumor…
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Lepu Medical Technology Receives NMPA Approval for MemoSorb Biodegradable PFO Occluder
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced receiving market approval from the National Medical Products Administration (NMPA) for its in-house developed MemoSorb biodegradable patent foramen ovale occluder. This innovative device is now approved for use in patients aged 18 to 60 with…
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Shanghai Roche Pharmaceuticals Launches Erlotinib for Advanced Non-Small Cell Lung Cancer in China
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Shanghai Roche Pharmaceuticals Ltd. made headlines in March with the launch of its lung cancer treatment, Erlotinib, in the Chinese market. This targeted therapy is designed for patients with advanced non-small cell lung cancer (NSCLC) that has continued to progress despite standard chemotherapy. Erlotinib’s mechanism of action involves the specific…
