Category: FDA Updates

FDA Updates

FDA Clears Deep Learning Technology for High-Resolution CT Imaging

The software is designed to enhance spatial resolution and suppress artifacts in pulmonary, musculoskeletal, and inner ear scans.

FDA Updates

Defibrillation Lead Wins FDA Approval for Conduction System Pacing

The defibrillation lead, approved for placement in the left bundle branch area, can deliver both life-saving shock therapy and physiologic pacing through the heart's natural electrical system.

FDA Updates

GE HealthCare Receives FDA Clearance for Three New MRI Systems

The SIGNA portfolio includes a helium-free 1.5T system, advanced 3T scanner, and AI-driven workflow platform designed to improve imaging efficiency.

Clearances

FDA Clears Silicon Photonics System for Lung Biopsy Procedures

The system integrates depth imaging technology directly into biopsy tools to improve tissue sampling accuracy during bronchoscopy.

Recalls

Fresenius Kabi Removes Ivenix Large-Volume Pumps

A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I 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.