FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...
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 ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
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 ...
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 ...
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 ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback