Category: FDA Updates

FDA Updates

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.

FDA Updates

FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound

Designed to reduce imaging artifacts during neurosurgery, the SonoClear System now has FDA Breakthrough Device status and is moving toward 510(k) submission.

FDA Updates

New Artificial Heart Technology Earns FDA Breakthrough Device Designation

The clinical-stage company earns the regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use.

Clearances

FDA Clears AI Tool to Help Detect Lung Nodules and Triage Chest X-Rays

New FDA clearances authorize the use of an AI tool to detect lung nodules and help triage pneumothorax and pleural effusion on chest X-rays.

Recalls

Smiths Medical Recalls Endotracheal Tubes Over Ventilation Risk

Devices are being removed from use after certain sizes were found to have smaller diameters than expected, potentially limiting airflow. Eight injuries have been 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.