JD Supra

What FDA’s TEMPO Pilot and CMS’s ACCESS Model Mean for Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the ...
JD Supra

FDA’s 2026 CDS and General Wellness Guidance Updates

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...

FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care

PRNewswire/ - MolecuLight today announced that its MolecuLightDX(R) wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The ...
MedTech Dive

FDA guidance eases wearables oversight. But experts have questions about what’s next.

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
Becker's Hospital Review

Device supply gaps put pediatric patients at risk: FDA

Device supply gaps put pediatric patients at risk by causing delays and forcing use of adult equipment, FDA says in recent safety alert.
Yahoo

FDA moves to rehire medical device, food safety and other staffers fired days earlier

WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...
STAT

Should Medicare automatically pay for medical devices that the FDA deems ‘breakthrough’?

Questions about cost and patient benefit loom as Congress considers automatic Medicare coverage for 'breakthrough' medical devices.
Yahoo

Chatbots Are Not Medical Devices

In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...
Penn Live

FDA rehires medical device staffers fired only days earlier

WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...