Category: FDA Updates

FDA Updates

FDA Clears AI Tool for Coronary Plaque Analysis

The clearance enables on-premise AI analysis of coronary CT angiography for quantifying calcified and non-calcified plaque.

FDA Updates

Tandem Issues Correction for t:slim X2 Insulin Pumps

A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.

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.

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

SunMed Holdings Removes Adult Manual Resuscitator Devices

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

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.