Category: FDA Updates

FDA Updates

FDA Launches Digital Health Pilot for Chronic Disease Technologies

The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.

FDA Updates

FDA Expands Early Alert Program for High-Risk Device Issues

The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.

FDA Updates

Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process

New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.

Clearances

AI-Driven Coronary Physiology Software Gains FDA Clearance

The software, powered by artificial intelligence and deep learning, assesses angiography-derived coronary physiology in patients with ischemic coronary artery disease.

Recalls

FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

Labeling

Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

Draft Guidances

FDA Proposes Ban on Electrical Stimulation Devices

The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.