Category: FDA Updates

FDA Updates

FDA Clears Avatar Medical Vision for 3D Imaging and Surgical Planning

The software supports CT and MR image visualization across standard displays, glasses-free 3D systems, and virtual reality environments.

FDA Updates

FDA Clears Wireless Maternal-Fetal Monitoring Platform

The wearable sensor system provides continuous, simultaneous monitoring of maternal and fetal vital signs to improve clinical evaluation.

FDA Updates

GE HealthCare’s Photonova Spectra Photon-counting CT Receives FDA Clearance

The cleared system introduces photon-counting CT designed to capture spectral data in a single scan and reduce protocol complexity.

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.