The new WHOOP MG offers real-time ECG scans, AI coaching, and blood pressure tracking, but the company's FDA clash could ...

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

Alongside the acquisition, the brand is launching Cycle & Ovulation Pro, a paid plug-in for the Ultrahuman Ring AIR that promises the most accurate ovulation tracking available on a smart ring with ...

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 ...

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

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

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

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

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

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

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