Regulatory

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....

Mirxes receives US FDA’s breakthrough device designation for blood-based cancer detection test

GASTROClear is the first miRNA blood test and the first gastric cancer molecular test globally to receive FDA Breakthrough Device Designation...

Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems...

Medcrypt Unveils FDA Cybersecurity Readiness Services for Med Device Firms

With Medcrypt's FDA Cybersecurity Readiness Services, MDMs can confidently navigate mandatory eSTAR for 510(k) submissions and the FDA's upcoming Cybersecurity Refuse To Accept Policy for other submission types, benefiting from a mock submission process with expert feedback and review....

Ten stakeholders jointly seek recall of India's New Drugs, Cosmetics & Medical Devices Bill 2023

Indian medical device manufacturers, patient interest groups, users and hospitals write to Union Health Minister Dr Mansukh L Mandaviya...

India launches first indigenously developed Magnetic Resonance Imaging (MRI) Scanner

Voxelgrids Innovations has developed the MRI Scanner under the National Biopharma Mission of Department of Biotechnology...

Singapore unveils Industry Transformation Map 2025 for healthcare

Renewing focus on primary and preventive health in medical training...

A dispute between industry & government's opinion on medtech sector?

Unfortunate to see PM’s ‘Make in India’ dream being bulldozed: AiMeD...

icotec ag's VADER® Pedicle System Navigated Instruments Gain FDA 510(k) Clearance for Safer Spinal Implantation

icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is pleased to announce the receipt of FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. This achievement represents a significant step forward in enhancing surgical precision and safety for spine surgeons using our innovative BlackArmor® Carbon/PEEK implants....