Category: FDA Updates

FDA Updates

FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller

The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.

FDA Updates

FDA Issues Class I Recall for Ambu Manual Resuscitators

The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.

FDA Updates

MDUFA VI Process Officially Begins With FDA Public Meeting

AdvaMed leaders call for a continued focus on timely patient access and regulatory predictability as the FDA opens discussions on the next medical device user fee agreement.

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.