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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 ...
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.
Whoop is betting on political connections and wellness claims to keep its blood pressure monitoring feature, despite FDA ...
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.
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.
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.
Whoop says FDA is ‘overstepping its authority' with warning about blood pressure feature By Ashley Capoot, CNBC and Brandon Gomez, CNBC • Published 22 mins ago • Updated 12 mins ago ...