WHOOP
TL;DR 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 debuted a feature not approved or certified by the authority.
Per a Bloomberg filing, the FDA is pressuring Whoop to disable its Blood Pressure Insights feature. This new app offers its wearers blood pressure estimates and related guidance to provide a holistic view of their well-being. However, the FDA and Whoop can’t seem to agree whether the MG’s feature constitutes a medical device and must go through the traditional regulatory channels.
WHOOP
Whoop’s marketing material claims that the MG is “not a medical device and cannot diagnose or manage medical conditions,” and, as a result, the FDA has no authority to “regulate the product.” However, the FDA seemingly believes otherwise, claiming that potentially erroneous blood pressure readings can harm those wearing the device. Regardless, Whoop reportedly has confirmed that it would not remove the feature, going against the recent trends of health tech firms relenting to the agency.
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Medical devices must go through the relevant FDA channels for testing and approval before being marketed and sold; this includes unproven and novel sensors on smartwatches and fitness trackers. While the process ensures consumers are offered clinically-approved products, it can take months, often resulting in features launching well after a device has debuted. The Fitbit Sense’s ECG sensor is a particularly memorable example of this. The FDA can demand fines from offending companies or even forbid their products from being sold. Still, the genuine issue appears to be the nebulous definitions of medical devices and modern fitness trackers.
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