Article Name 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 ...Read more

16th August, 2023


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...Read more

16th August, 2023


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...Read more

14th August, 2023


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...Read more

10th August, 2023


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, benefiti...Read more

10th August, 2023


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...Read more

07th August, 2023


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...Read more

07th August, 2023


Singapore unveils Industry Transformation Map 2025 for healthcare

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

04th August, 2023


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

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

01st August, 2023


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 ...Read more

28th July, 2023


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