Whoop Won't Remove Blood Pressure Insights at FDA's Request
Whoop maintains its blood pressure monitoring feature on the Whoop MG despite FDA warnings that the device requires certification as a medical device.
6 Articles
6 Articles
Whoop there it is: FDA wants to regulate wearable firm’s blood pressure tool - The Boston Globe
Wearable technology sits in a grey area when it comes to regulation. Whoop says the software tool doesn't meet the definition of a medical device and shouldn't be regulated as such.
Blood pressures rise as the FDA cracks down on this wearable's flagship feature
Credit: WHOOP The FDA has scrutinized Whoop for a new wellness monitoring feature that has not been certified. The FDA considers the Whoop MG (Medical Grade) a medical device and should remove the Blood Pressure Insights feature until approved. Whoop claims the product is not for medical use and will not disable the feature. Wellness wearable maker Whoop, specifically one of its latest fitness bands, has drawn the ire of the FDA after it debute…
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