Category: FDA Updates

FDA Updates

Medtronic Receives FDA Clearance for Pulse Oximetry System

The new technology is designed to improve oxygen saturation monitoring reliability across diverse skin tones and patient populations.

FDA Updates

Medical Device Recalls Declined in Q1 2026 Amid FDA Quality System Changes

Sedgwick’s latest report shows fewer medical device recall events in Q1 2026, while sterility-related recalls drove the majority of impacted units.

FDA Updates

FDA Issues Safety Guidelines for Charging Medical Devices to Prevent Overheating

The agency recommendations emphasize using manufacturer-authorized accessories and avoiding overnight charging to reduce fire and injury risks.

Clearances

FDA Clears Philips AI-Powered Spectral CT Imaging System

The system uses artificial intelligence for image reconstruction to improve diagnostic precision and workflow efficiency in radiology, cardiology, and oncology.

Recalls

Philips Issues Correction for Trilogy Evo Ventilators Following FDA Class I Recall

The Food and Drug Administration identifies the software update and nebulizer restrictions as the most serious type of recall.

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.