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Shanghai Bio-heart Launches SAKURA-SCB Study for Drug-Coated Balloon in Japan
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China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced the first patient enrollment for the SAKURA-SCB study at the Cardiovascular Institute in Tokyo, Japan. This single-blinded, multiple comparison study aims to evaluate the efficacy and safety of the company’s investigational drug-coated balloon (DCB) with rapamycin. DCB InnovationThe DCB, designed…
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Sanofi’s Qfitlia Approved by FDA for Hemophilia A and B Prophylaxis
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval from the US Food and Drug Administration (FDA) for Qfitlia (fitusiran). This antithrombin-lowering (AT) therapy is now approved for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A…
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China Tightens Medical Device Quality Oversight: 2025 Inspection Plan Unveiled
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China’s National Medical Products Administration (NMPA) has released its 2025 medical device inspection plan, outlining stricter quality oversight and compliance requirements. The new guidelines aim to enhance product safety, enforce regulatory standards, and streamline market access for domestic and international manufacturers. Key Policy Highlights Impact on Medical Device Manufacturers Reinspection…
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China Unveils 2025 Medical Device Inspection Strategy to Tighten Quality Control
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China’s National Medical Products Administration (NMPA) convened a pivotal conference in Chengdu on March 24 to outline its 2025 medical device inspection agenda. The meeting highlighted achievements from 2024, including enhanced product quality and public safety, while emphasizing stricter compliance frameworks to address evolving industry risks. 2024 Progress and 2025…
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Abbott Laboratories’ Volt PFA System Receives EU CE Mark for Atrial Fibrillation Treatment
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US-based Abbott Laboratories (NYSE: ABT) has announced the receipt of the CE mark in the European Union (EU) for its Volt PFA System, a novel therapy for patients with atrial fibrillation (AFib). This approval marks a significant advancement in treatment options for AFib, particularly for those with complex conditions. Technology…
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Shanghai ZJ Bio-Tech’s HCV Nucleic Acid Test Kit Receives NMPA Approval
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China-based molecular diagnostic reagent specialist Shanghai Liferiver Bio-Tech Co., Ltd (SHA: 688317) has announced receiving Category III medical device license from the National Medical Products Administration (NMPA) for its hepatitis C virus (HCV) nucleic acid test kit (fluorescent PCR method). This product is designed for the quantitative detection of HCV…
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China’s NHSA Releases 2024 Healthcare Security Bulletin Highlighting Insurance Coverage and Reimbursement
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China’s National Healthcare Security Administration (NHSA) has released its 2024 “Healthcare Security Development Statistical Bulletin.” The report reveals that by the end of 2024, over 1.33 billion people were enrolled in Basic Medical Insurance (BMI) schemes, maintaining a coverage rate of over 95%. Maternity insurance participation reached 252.98 million, an…
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Jenscare Scientific’s Ken Valve Receives NMPA Marketing Approval
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Jenscare Scientific Co., Ltd (HKG: 9877), a Ningbo-based structural heart disease device maker, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its transcatheter artificial aortic valve system Ken Valve. The company is now preparing for the commercialization of the product. Product Design and AdvantagesThe in-house…
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Oriomics’ Liver Cancer Screening Reagent Earns FDA Breakthrough Device Designation
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Hangzhou-based Oriomics, a cancer screening specialist backed by Hotgen Biotech Co., Ltd (SHA: 688068), has obtained Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its liver cancer multi-gene methylation + protein multi-omics screening reagent and supporting analysis software. This recognition highlights the innovative nature of…
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NMPA Updates Rules on Domestic Production of Imported Medical Devices
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The National Medical Products Administration (NMPA) has released a notification on further adjusting and optimizing matters relating to the domestic production of imported medical devices by companies within China, effective immediately. This update aims to streamline the regulatory process and support the localization of production for imported medical devices. Key…
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Broncus Medical’s BroncQCT Approved by Zhejiang Administration for China Market Entry
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Broncus Medical Inc., a provider of precision intervention solutions for lung diseases with operations in Shanghai, Hangzhou (China), and San Jose, Seattle (United States), has received approval from the Zhejiang Medical Products Administration to market its BroncQCT lung image processing software in China. Software FunctionalityBroncQCT processes CT images through advanced…
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Lifetech Scientific’s LAmbre Plus LAA Closure System Gains US Medical Insurance Coverage
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced obtaining medical insurance coverage in the United States for an FDA-approved pre-clinical study of its proprietary LAmbre Plus Left Atrial Appendage (LAA) Closure System. This marks the first time a home-grown left atrial appendage closure device from China has achieved this milestone.…
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GE Healthcare Unveils Invenia ABUS Premium for Enhanced Dense Breast Screening
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US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) has announced the launch of the Invenia Automated Breast Ultrasound (ABUS) Premium. This advanced 3D ultrasound system integrates artificial intelligence (AI) and innovative features to enable faster, reproducible supplemental screening and streamline exam readings for patients with…
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Telix Pharmaceuticals Gains Brazilian Approval for Prostate Cancer Diagnostic Agent TLX591-CDx
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) announced receiving clearance from the Brazilian Health Regulatory Agency for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer. This approval allows the drug to be used in positron emission tomography (PET) for detecting prostate-specific membrane…
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GE Healthcare Launches AltiX AI.i Edition for Enhanced Cardiac Procedures
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US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) announced the introduction of the AltiX AI.i edition of Mac-Lab, CardioLab, and ComboLab. These advanced systems are designed to enhance the management of various cardiac procedures through integrated solutions and artificial intelligence. Product Integration and InnovationComboLab combines…
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IceCure Medical Secures Chinese Patent for Cryogenic System Connector
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Israel-based IceCure Medical Ltd. (NASDAQ: ICCM) announced receiving patent authorization from the China National Intellectual Property Administration for its invention titled “Cryogenic System Connector.” This patent underscores the company’s commitment to advancing its minimally-invasive cryoablation technology. Cryoablation Technology InnovationIceCure’s technology focuses on destroying tumors through freezing, offering a less invasive…
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Lifetech Scientific’s Aortic Stent System Approved by China’s NMPA
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China-based Lifetech Scientific Corporation (HKG: 1302) announced receiving market approval from the National Medical Products Administration (NMPA) for its aortic branch reconstruction covered stent system (chimney), co-developed with Fuwai Hospital. This innovative product offers a novel treatment option for patients with arch lesions. Product InnovationThe aortic branch covered stent system…
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ROBO Medical’s Innovative Gastrointestinal Endoscopic Instrument Gains NMPA Approval
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China’s National Medical Products Administration (NMPA) has approved ROBO Medical’s gastrointestinal endoscopic surgical instrument control equipment, an innovative product now eligible for clamping and pulling diseased tissues during submucosal dissection of esophagus and stomach endoscopy. Product InnovationThis product, the first home-grown digestive endoscopic integrated robot in China, features a flexible…
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Inari Medical Wins NMPA Approval for Thrombectomy Stent System in China
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US-based Inari Medical, Inc. (NASDAQ: NARI), set to be acquired by Stryker (NYSE: SYK), announced last week that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its peripheral vein thrombectomy stent system. This marks a significant milestone in the company’s global expansion strategy. Product DetailsThe…
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MicroPort Endovascular MedTech’s Cratos System Approved for Aortic Dissection Treatment
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Shanghai MicroPort Endovascular MedTech Co., Ltd’s (SHA: 688016) Cratos branched aortic stent graft system has received marketing approval from China’s National Medical Products Administration (NMPA). The approval is for the minimally invasive interventional treatment of thoracic aortic dissection involving branches of the aortic arch. Product InnovationThe Cratos system represents an…
