Category: FDA Updates

FDA Updates

Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking

The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.

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.

Clearances

FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound

The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.

Recalls

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.

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.