Category: FDA Updates

FDA Updates

FDA Clears New Software for Draeger Evita V800 Ventilator

The update introduces features designed to assist clinicians in managing patients with pulmonary diseases like acute respiratory distress syndrome.

FDA Updates

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.

FDA Updates

FDA Clears New Neurosurgical Navigation System for Brain Procedures

The system uses artificial intelligence to provide real-time guidance for brain biopsies, shunt placements, and other neurosurgical procedures.

Clearances

FDA Clears Hybrid Heart Imaging System

The platform combines ultrasound and optical imaging to provide detailed views of coronary anatomy in a single workflow.

Recalls

Philips Issues Correction for Trilogy Evo Ventilators Following FDA Class I Recall

The Food and Drug Administration identifies the software update and nebulizer restrictions as the most serious type of recall.

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.