The Food and Drug Administration on Tuesday released two final guidance documents that would loosen regulations for certain types of wellness and software products. FDA Commissioner Marty Makary ...

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

Boston-based wearable fitness company WHOOP has publicly responded to the FDA's letter from July, stating that its Blood Pressure Insights feature does not need FDA approval as it is a wellness ...

FDA updated its General Wellness policy to clarify and take a step back from previous positions on health and wellness technology. The Food and Drug Administration (“FDA”) unexpectedly updated its ...

The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a ...

Please provide your email address to receive an email when new articles are posted on . The SONU Band was initially approved for adults aged 22 years and older with moderate to severe nasal congestion ...

The FDA will not regulate wearable devices that provide nonmedical-grade health information, a move aimed at giving technology companies clearer guidance as AI-driven health tools proliferate, Fox ...

A device that is a noninvasive, drug-free way to treat and prevent migraine headaches is now FDA-approved for use in children. Millions of people suffer from migraine headaches that can be ...

In February, Edinburgh, Scotland-based Current Health (formerly snap40) received FDA clearance for clinical use of its artificial intelligence-enabled device and platform for remote patient monitoring ...

WHOOP’s $575 million funding round brings on major healthcare institutions, as the wearable company pushes beyond wellness ...