The FDA has scrutinized Whoop for a new wellness monitoring feature that has not been certified. The FDA considers the Whoop ...

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

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

Whoop Inc., the maker of screen-less fitness bands, said it will not disable its blood-pressure tracking tool despite a request from the US Food and Drug Administration.

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.

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

The FDA’s warning letter to Whoop Inc. resurrects questions about the agency’s observance of the 21st Century Cures Act in ...

Scott Kirsner, a columnist from our editorial partner MassLive, joins WBUR's Morning Edition to discuss the feud.