GlobalData on MSN

FDA announces regulatory exemptions for ‘non-medical grade’ devices

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
Medical Device and Diagnostic Industry (MD+DI)

FDA’s New Rules for Wearables

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
MedTech Dive

FDA exempts more wearable, AI features from oversight

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
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 ...

FDA commissioner says non-medical-grade wearable data exempt from regulation

The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...
Fierce Healthcare

FDA paves way for more consumer wearables to hit the market, eases regulation of AI-enabled devices

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
American Hospital Association

FDA issues guidance on wellness products, clinical decision support software

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
Becker's ASC

FDA Releases Final Rule on Software, Hardware Used With Medical Devices

The Food and Drug Administration has finalized a regulation that provides a less-burdensome path to market for certain hardware and software products used with medical devices, according to an FDA ...
PharmExec

FDA Limits Regulations on Non-Medical Grade Wearable Fitness Devices

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...
JD Supra

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of ...
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 ...
JD Supra

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that ...