Regulatory

Indian Medtech Startup Sigtuple Earns First FDA Approval in India's Space

SigTuple’s AI100 with ShonitTM receives U.S. FDA 510(k) Clearance...

4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate

Company Continues to Build Momentum with Most Recent Portfolio Expansion....

Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Patients implanted with the Evoke® System now eligible for full-body MRI scans...

Qure.ai receives 510(k) FDA clearance for chest X-ray solution for Pneumothorax and Pleural Effusion

A monumental step towards getting healthcare AI to augment critical care and emergency care...

Genesis MedTech Introduces China's First NPMA-Approved Antibacterial Sutures

Genesis MedTech, a leading medical device company, announced that its absorbable sutures with antibacterial protection have successfully obtained approval from the China's National Medical Products Administration (NMPA) for market release....

Alveofit receives US FDA clearance for alveoair spirometer

Marking a significant advancement in respiratory care...

"We are coming up with CoEs for health science & medical devices": Priyank Kharge

Priyank Kharge, Minster for IT BT, Government of Karnataka speaking at the Global Innovation Alliance (GIA) Partners Meet held on August 28, 2023 in Bangalore...

Bio-Gate AG signs LOI with North American medical device manufacturer for trauma implants

Bio-Gate AG (ISIN DE000BGAG981), a leading provider of innovative technologies and individual solutions for health and hygiene, has concluded a preliminary agreement (LOI, Letter-of-Intent) with a North American medical device manufacturer focusing on the trauma sector. The medical device manufacturer intends to use Bio-Gate's "HyProtectTM " coating process for its own implants in human medicine following the FDA approval process. ...

CathVision's AI EP Recording System Gains FDA Clearance for Cardiac Ablation Success Measurement

ECGenius System with CARDIALYTICS Algorithms Provides Unprecedented Levels of Automated Analyses Derived from High-Fidelity, Low-Noise Cardiac Signals ...

CareBand Obtains US Patent for IoT Wearable System Safeguarding Vulnerable Individual

CareBand, a pioneer in low-powered location-based health and safety wearable solutions, celebrates the granting of US Patent No 11,714,197. This milestone further strengthens CareBand's position as a leading innovator in the rapidly growing LPWAN market....