FDA Related News

Medical Devices

Getinge 510(k) for Software Update to Ventilators

FDA clears a Getinge 510(k) for a new software version for the Servo-u and Servo-n mechanical ventilator platform.

Medical Devices

Avinger Small Vessel Atherectomy System Cleared

FDA clears an Avinger 510(k) for its Pantheris SV (Small Vessel) image-guided atherectomy system.

Human Drugs

Meeting on Responsible Innovation in Dietary Supplements

FDA announces a 5/16 public meeting entitled Responsible Innovation in Dietary Supplements.

Human Drugs

FDA Developing Ways to Predict Drug Effects Before Trials

A CDER Regulatory Science Impact Story describes Center researchers efforts to develop microengineering human cellular system to predict drug toxicity...

Human Drugs

FDA Expanding Real-World Evidence Demonstration Project

FDA expands its RCT DUPLICATE demonstration project to use real-world evidence to estimate results of seven Phase 4 trials.

Medical Devices

FDA Denies Helius De Novo App for Neuromodulation Stimulator

FDA denies a Helius Medical Technologies de novo marketing request for its Portable Neuromodulation Stimulator device for treating patients with chron...

Human Drugs

Bedfont 510(k) Cleared for Carbon Monoxide Monitor

FDA clears a Bedfont 510(k) for its ToxCO carbon monoxide (CO) breath analysis monitor which determines levels of carbon monoxide poisoning.

Companies, Individuals Settle FTC Geniux Charges

The Federal Trade Commission says corporate and individual defendants have resolved cognitive improvement supplement deceptive marketing charges.

Medical Devices

Dont Use Uncleared, Unapproved Devices for Concussion: FDA

FDA cautions against using unapproved or uncleared medical devices to diagnose, treat, or manage head injuries, including concussions.

Invidior Indicted for Illegal Suboxone Marketing

A federal grand jury indicts Invidior for illegal misleading marketing of its Suboxone Film opioid-addiction treatment.