Category: FDA Updates

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.

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.

Clearances

FDA Clears New Device for Transseptal Heart Access

The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.

Recalls

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.

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.