8. Guidance document: Off-The-Shelf Software Use in Medical Devices FDA itself has said that section 3.2.2 of this guidance is out-of-date because it characterizes laboratory information management ...

Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of neurological and physical medicine devices, which is in charge of regulating ...

GE HealthCare Technologies Inc. (NYSE: GEHC) leads with 100 FDA-approved AI devices, concentrating heavily on imaging and diagnostics. Their CleaRecon DL technology sharpens cone-beam CT images using ...

In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...

A new proposal in JAMA Internal Medicine suggests that the FDA should create an approval pathway for medical AI tools that parallels how physicians are trained and licensed.

To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission ...

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...

The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...

Artificial intelligence (AI) is no longer the future of healthcare—it’s already here. AI-driven medical devices are diagnosing diseases faster than doctors, guiding surgical procedures with precision ...