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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 is betting on political connections and wellness claims to keep its blood pressure monitoring feature, despite FDA ...
According to a formal warning letter issued to the company, the FDA believes the feature amounts to an unapproved medical ...
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 ...
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.
The company’s Whoop MG is the subject of a disagreement with the US Food and Drug Administration (FDA) over whether it acts ...
In response, Whoop pulled out the W word: wellness.
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