Category: FDA Updates

FDA Updates

Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue

The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.

FDA Updates

3M Company Corrects Ranger Blood/Fluid Warming System

The action addresses a discrepancy between the device's labeled and actual performance at high flow rates, which could pose a risk of patient hypothermia.

FDA Updates

Hamilton Medical Removes Breathing Circuits Over Serious Ventilation Risk

The devices may have cracks that could lead to patient rebreathing of exhaled gases.

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

Philips Respironics Updates Use Instructions for Certain BiPAP Devices

Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.

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.