Category: FDA Updates

FDA Updates

FDA Approves Implantable Device for Urge Urinary Incontinence

The tibial neuromodulation therapy is designed with a 15-year battery life and is MRI-compatible.

FDA Updates

FDA Announces Class I Recall for ICU Medical Infusion Pump

A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.

FDA Updates

FDA Issues Early Alert on Infusion Pump Issue from Baxter

The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.

Clearances

AI-Driven Coronary Physiology Software Gains FDA Clearance

The software, powered by artificial intelligence and deep learning, assesses angiography-derived coronary physiology in patients with ischemic coronary artery disease.

Recalls

Medtronic Recalls Certain Newport Ventilators and Related Service Parts

Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.

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.