FDA Launches ‘Elsa’ AI Tool to Enhance Staff Efficiency in Regulatory Processes
The U.S. Food and Drug Administration (FDA) announced the launch of an artificial intelligence (AI)...
Medical Device
Allgens Medical’s SkuHeal Artificial Bone Repair Material Gains Vietnam Marketing Approval
Beijing-based regenerative medicine materials and implantable device maker Allgens Medical Technology Co., Ltd (SHA: 688613)...
Mindray Bio-Medical Expands North American Warehouse to Enhance Operational Efficiency
China-based Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (SHE: 300760) announced the groundbreaking of its North...
3D Medicines Partners with MGI Tech for Precision Medicine Solutions in Oncology and Infectious Diseases
China-based 3D Medicines (HKG: 1244) announced a strategic collaboration with domestic gene sequencing specialist MGI...
Thermo Fisher Mulls $4B Diagnostic Business Sale Amid Healthcare Sector Turbulence
US-based life sciences giant Thermo Fisher Scientific Inc. (NYSE: TMO) is reported by the Financial...
Gene Solutions Partners with Topgen Biopharm to Advance Precision Oncology in Asia
Vietnam-based Gene Solutions, a provider of genetic tests and non-invasive prenatal testing (NIPT) for women’s...
Varian Medical Systems Secures NMPA Approval for Ethos 2.0 AI Radiotherapy Platform
US-based Varian Medical Systems (NYSE: VAR) announced that it has received marketing approval from China’s...
NMPA Issues Immediate Guidelines for NGS-Related IVD Reagent Classification
China’s National Medical Products Administration (NMPA) released the “Guidelines for Classification Definition of Next-Generation Sequencing...
Tawada Healthcare Secures Series A+ Funding Led by Highlight Capital
Indonesian integrated medical equipment service provider Tawada Healthcare (THC) has reportedly raised “tens of millions”...
Suzhou Sinus Medtech Wins FDA Breakthrough Designation for oHCM Ablation System
Suzhou Sinus Medical Technologies Co., Ltd., a China-based medical device innovator, announced that its in-house...
Genesis MedTech Wins NMPA Approval for Locally Developed Thrombus Aspiration Catheter
Singapore-based Genesis MedTech announced that it has received marketing approval from China’s National Medical Products...
Acotec Scientific Gains NMPA Approval for AcoArt Verbena Vertebral Balloon
China-based Acotec Scientific Holdings Ltd (HKG: 6669) has received marketing approval from China’s National Medical...
Bio-heart Launches Iberis Renal Ablation System at OCC 2025
China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) hosted the product launch of its...
EU Bars Chinese Medical Device Makers from Public Tenders Over €5M for Five Years
China Central Television (CCTV) reported that EU member states have voted under the International Procurement...
Acotec Scientific’s E-Peridge Balloon Catheter Approved by China’s NMPA
China-based Acotec Scientific Holdings Ltd (HKG: 6669) announced that it has received marketing approval from...
Abbott Laboratories Receives FDA Approval for Tendyne TMVR System
US-based medical device giant Abbott Laboratories (NYSE: ABT) announced that it has received marketing approval...
Sino Medical Sciences Technology’s AUCURA Flow-Diverting Stent Approved by NMPA
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that its holding subsidiary Neurovita has...
China’s NMPA Approves Lifetech’s Aortic Fenestration Stent System
China’s National Medical Products Administration (NMPA) recently approved an innovative aortic in-situ fenestration branch reconstruction...
Jenscare Announces Positive 30-Day Results for LuX-Valve Plus in TRINITY Study
Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced the...
Medtronic’s Prevail DCB Gains CE Mark for Expanded Coronary Disease Indications
US-Irish firm Medtronic (NYSE: MDT) announced that its Prevail paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA)...