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 ...
JD Supra

Digital Health Policy: FDA Relaxes Restrictions over Wearables and AI Decision Making Tools in Two New 2026 Guidances

On January 6, 2026, the U.S. Food & Drug Administration (FDA) updated two guidance documents, General Wellness: Policy for Low Risk Devices ...
Medical Device Network

KORU Medical receives FDA clearance for FreedomEDGE infusion system

KORU Medical Systems has received the US FDA 510(k) clearance to use its FreedomEDGE infusion system for administering Rystiggo.
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 ...
JD Supra

AI Trends For 2026 - How AI Is Rewiring Clinical Workflows and Medical Devices

AI tools in healthcare are no longer just boosting efficiency. They are reshaping how care is delivered, managed, and personalized. Below are the ...
Medical Device and Diagnostic Industry (MD+DI)

How Medical Device Companies Can Avoid Costly FDA Inspection Mistakes

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
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 ...