Category: FDA Updates

FDA Updates

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.

FDA Updates

Boston Scientific Receives FDA Clearance for Asurys Fluid Management System

Device is designed to regulate irrigation and intrarenal pressure during endoscopic urologic procedures

FDA Updates

FDA Clears Platform for Noninvasive Cardiac Conduction System Visualization

The CTA-based system creates a patient-specific 3D map of the cardiac conduction system to support planning and guidance during procedures such as TAVR and conduction system pacing.

Clearances

FDA Clears 3T Neonatal MRI System Designed for Use in the NICU

The system features a compact footprint and is designed for whole-body imaging in neonatal care settings.

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.