Category: FDA Updates

FDA Updates

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.

FDA Updates

FDA Flags Medical Device Testing Firm for Submitting Falsified or Copied Data

The FDA determined that the company has submitted copied, falsified, or otherwise invalid data in submissions to the agency.

FDA Updates

FDA Cautions Medical Device Shortage Could Affect Children

The FDA warned of a shortage of pediatric medical devices and urged Congress to bolster its ability to track and anticipate these issues.

Clearances

HeartBeam Arrhythmia Assessment System Earns FDA Clearance

HeartBeam announced that the FDA has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment.

Recalls

Philips Updates Users About Aerosol Risk for Ventilators

Philips has updated instructions for several ventilators to address aerosol deposits on internal sensors when used with in-line nebulizers.

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.