Medical Devices

CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Innovation Across Europe

With CE Mark certification, the AI-powered ECGenius System is now approved for commercialization in the European Economic Area, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....

Philatron Wire & Cable Unveils FlexyCord™ – The Ultimate Retractile Cord for Medical & Healthcare Applications

Engineered for precision, durability, and space efficiency, the patented FlexyCord™ coiled cable delivers unmatched reliability in critical medical environments. ...

QuantalX Secures CE MDR Approval for Delphi-MD, Paving the Way for EU Commercialization

Breakthrough Neurodiagnostic Device Aims to Transform Early Detection and Treatment of Neurological Disorders Across Europe...

NX Taiwan Secures TFDA Certification for Medical Device Quality Management—A First for a Japanese Company

Nippon Express (Taiwan) Co., Ltd. earns medical device QMS certification for its NEXT3 warehouse in Taoyuan, reinforcing its capabilities in compliant storage, packaging, and labeling of medical devices to meet Taiwan’s stringent quality control standards. ...

Sanofi’s Merilog Wins FDA Approval as First Rapid-Acting Insulin Biosimilar for Diabetes

The U.S. FDA has approved Merilog (insulin-aspart-szjj), Sanofi’s biosimilar to Novolog, marking a significant step toward expanding access to affordable insulin. The approval strengthens competition in the diabetes treatment market, offering a new rapid-acting insulin option for millions of patients. ...

Navi Medical Secures FDA Clearance for Neonav® Pediatric Vascular Access System

The first-of-its-kind system, designed specifically for neonatal and pediatric patients, leverages real-time ECG signal analysis to improve CVAD placement, enhance patient safety, and reduce complications, marking a major milestone in global pediatric healthcare....

MedTech Catapult Launches at Biopolis to Boost Singapore’s MedTech Innovation

Dr Tan See Leng officiates the launch, introducing a vital directory to connect MedTech innovators with trusted local manufacturing partners, marking a new era for Singapore’s MedTech ecosystem....

Medera’s Novoheart expands cardiac research with CTScreen™ at Utrecht Medical Center

New installation enhances human heart disease modeling and drug discovery capabilities....

BlueWind Medical’s Revi® System shows sustained efficacy over two years in peer-reviewed study

Clinical data confirms long-term durability of results for the Revi® System in treating overactive bladder....

PHC and CCRM Partner to Optimize T-Cell Expansion for Advanced Cell Therapies

Collaboration aims to enhance efficiency and improve cell quality in primary T-cell culture processes....