As China rises and other global cities aggressively court biotech talent, Massachusetts faces a "contracting moment" that has ...

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.

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

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 ...

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 ...

The Apple Watch function that measures blood-oxygen levels had been disabled since a 2023 patent-infringement case.

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