Category: FDA Updates

FDA Updates

FDA Issues Alert for Medtronic Esophageal Monitoring Devices

The agency warns of potential high-risk issues with Bravo CF delivery systems following reports of 184 serious injuries.

FDA Updates

FDA Issues Early Alert for Becton Dickinson Needle Sets Following Reports of Injuries and Deaths

The agency warns of a high-risk issue where needle components may lock during insertion, potentially delaying critical care.

FDA Updates

FDA Clears New Contrast-Enhanced Breast Imaging Capabilities for Mammomat B.brilliant

The newly cleared contrast-enhanced mammography and biopsy capabilities aim to help radiologists characterize suspicious findings and perform targeted biopsies more efficiently.

Clearances

Philips Adds AI Measurement and Lesion Classification Tools to Ultrasound Systems

The FDA-cleared update automates measurement tasks and provides clinical decision support to improve imaging workflow.

Recalls

React Health Removes VOCSN V+Pro Ventilators

A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.

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.