FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health technology and AI policies.

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less regulatory oversight.

DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...

On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS ...

By Puyaan Singh Jan 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing ...

A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes ...

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

A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3]; and Robert M. Califf[4], MD in the Journal of the American Medical Association, reviews the history of artificial ...

A recent report said medical device software is under-regulated and recommended the Food and Drug Administration develop procedures to ensure the safety and efficacy of products before they go to ...