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.

Whoop is betting on political connections and wellness claims to keep its blood pressure monitoring feature, despite FDA ...

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

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

Whoop has previously received FDA clearance for its ECG feature, which is used to record and analyze a heart's electrical activity to detect potential irregularities in rhythm.

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying ...

In response, Whoop pulled out the W word: wellness.

Whoop has previously received FDA clearance for its ECG feature, which is used to record and analyze a heart's electrical activity to detect potential irregularities in rhythm.