Category: FDA Updates

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.

FDA Updates

FDA to Exempt Several Unclassified Medical Devices from Premarket Notification

New guidance identifies low-risk devices in eight medical specialties that will no longer require 510(k) submissions to reduce regulatory burdens.

FDA Updates

FDA Issues Alert for Draeger Atlan Anesthesia Workstations

Draeger expands its correction for Atlan models due to potential mechanical ventilation failure.

Clearances

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.

Recalls

FDA Issues Alert for Aligned Medical Solutions Angiographic Syringe Kits

The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.

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.