Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...

Medical Devices includes a session from a regulatory expert on how companies can align their research between regions.

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...

Vektor Medical, a medical technology company transforming cardiac arrhythmia care, announced key milestones achieved in 2025, a year defined by progress, innovation, and growth. Vektor's flagship ...

Innovative Health, Inc. today announced that the company has received its 50th clearance from FDA to reprocess single-use medical devices used in electrophysiology and cardiology labs. This latest ...

The results of this study provide further clinical evidence that patient-applied, patch-based PSG is a viable alternative to in-lab PSG, enabling broader access to gold-standard sleep testing.

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of ...