JD Supra

FDA Clinical Decision Support Software Guidance Refresh : Clearer Rules, Broader Innovation

On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...

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 ...
Medical Device Network on MSN

FDA clears RevealDX’s AI lung nodule diagnostic

RevealDX’s software analyses CT scans and assigns lung nodules with a Malignancy Similarity Index score to aid in lung cancer ...

As Healthcare AI Changes On The Fly, FDA Reconsiders How To Keep It Safe

The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not ...
MobiHealthNews

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...
JD Supra

The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
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 ...
MobiHealthNews

FDA issues guidance on predetermined change control plan for AI-enabled device software functions

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...
Dark Reading

FDA's Critical Role in Keeping Medical Devices Secure

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...