Category: FDA Updates

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.

FDA Updates

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.

Clearances

FDA Clears for Augmented Reality Navigation Platform for Neurosurgery

The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.

Recalls

Baxter Removes Sigma Spectrum Infusion System Platforms

The removal is tied to incorrect software installations that could result in inaccurate flow rates and user confusion during clinical use.

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.