Category: FDA Updates

FDA Updates

FDA Clears Updated Hermia Voxel Dosimetry Software

The new release adds machine learning–based organ segmentation, faster dose calculations, and automated workflow features.

FDA Updates

SunMed Holdings Removes Adult Manual Resuscitator Devices

The Class I recall involves devices with incorrectly assembled B/V filters.

FDA Updates

Zyno Medical Recalls Infusion Pumps Over Software Issue

Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.

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

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.