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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

Boston-based wearable fitness company WHOOP has come under scrutiny from the FDA for its Blood Pressure Insights feature, which the agency claims is being marketed improperly without proper regulatory ...

Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the ...

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