Category: FDA Updates

FDA Updates

FDA Clears Abbott Dual-Energy Cardiac Ablation Catheter

The TactiFlex Duo combines pulsed field ablation and radiofrequency energy in a single catheter for treating patients with atrial fibrillation.

FDA Updates

FDA Issues Early Alert for Becton Dickinson Convenience Kits

Certain procedure trays contain recalled sodium chloride ampules that may pose a risk of infection or organ failure.

FDA Updates

Fresenius Kabi Issues Correction for Ivenix Infusion Pumps Following Impact Damage

The Food and Drug Administration classifies the recall as the most serious type after reports of touchscreen malfunctions caused by dropped or jarred devices.

Clearances

FDA Clears 3D Imaging Platform for Existing Surgical C-Arms

The CBeam system enables 3D visualization using existing hospital infrastructure during orthopedic and neurological procedures.

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.