The Boston wearables firm says the software tool doesn't meet the definition of a medical device and shouldn't be regulated ...

Whoop Inc., the maker of screen-less fitness bands, said it will not disable its blood-pressure tracking tool despite a ...

The company’s Whoop MG is the subject of a disagreement with the US Food and Drug Administration (FDA) over whether it acts ...

The Whoop MG launched in May with a novel Blood Pressure Insights feature. Now, the FDA wants the company to disable it.

According to a formal warning letter issued to the company, the FDA believes the feature amounts to an unapproved medical ...

The company's CEO defended its feature as a wellness tool under the 21st Century Cures Act, combatting the FDA’s claim that it qualifies as a regulated medical device.

Despite the FDA’s requests to remove the blood pressure tracking tool in Whoop’s new fitness tracker, the company has ...

The Whoop MG is the company's latest display-less tracker, but a recent report states it's in hot water with the FDA.

Ultrahuman announced a major step forward in women’s health tracking by acquiring viO HealthTech, the medical tech company ...

WHOOP CEO Will Ahmed says the US Food and Drug Administration is wrong about the company's blood oxygen tracker. Ahmed argues ...

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

The disclosure in a filing Thursday gave a much-needed boost to the beleaguered health insurance giant, which saw shares jump as much as 9.6% in post-market trading. In other news: Nike co-founder ...