Category: FDA Updates

FDA Updates

Olympus Receives FDA Clearance for Open Surgery Sealing Device

The new Powerseal Open Extended Jaw device is the fourth addition to the company's advanced bipolar surgical energy portfolio.

FDA Updates

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.

FDA Updates

Philips Receives FDA Clearance for AI Software to Guide Mitral Valve Repair

EchoNavigator with DeviceGuide uses AI to track and visualize repair devices in real time during minimally invasive procedures.

Clearances

FDA Clears Single-Use Articulating Laparoscope for Minimally Invasive Surgery

The 5mm Saberscope features a 90-degree articulating tip and integrated camera designed to reduce fogging and eliminate reprocessing needs.

Recalls

Fresenius Kabi Issues Critical Software Update for Ivenix Infusion Pumps

FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.

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.