Regulatory

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 provid...Read more

20th February, 2025


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...Read more

18th February, 2025


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 ...Read more

17th February, 2025


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 trea...Read more

17th February, 2025


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 majo...Read more

17th February, 2025


Evolus Secures FDA Approval for Evolysse™ Hyaluronic Acid Gels

New Evolysse™ Form and Smooth injectables enhance aesthetic treatment options....Read more

14th February, 2025


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....Read more

10th February, 2025


Wyss Center Partners with BrainScape Medical to License Groundbreaking Epios® Technology

The collaboration aims to drive long-term brain monitoring and neurostimulation innovations into clinical applications....Read more

06th February, 2025


BD Announces Intent to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth and Unlock Value

Compelling opportunity expected to unlock substantial value through enhanced focus, tailored investment and capital allocation, and optimized market valuation ...Read more

06th February, 2025


Womens Wellness brand NUA Raises Rs 35 Crore in Pre-Series C led by Mirabilis Investment Trust

● Round also saw participation from notable investors including Samir Singh, EVP - Asia, Colgate Palmolive & Former Chair of Unilever SE Asia, Shuchi Kothari, Head of DSP Family Office and SRF Limited ● ...Read more

06th February, 2025


Artificial Intelligence Breakthroughs

Robots In Medtech

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