Category: FDA Updates

FDA Updates

FDA Issues Alert for Aligned Medical Solutions Angiographic Syringe Kits

The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.

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.

Clearances

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.

Recalls

GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals

The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.

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.