(Credit: Whoop)
Whoop wearables are known for high-end wellness tracking with a screen-less device. Its Whoop MG, announced in May, added blood pressure monitoring, a feature that is now central to a debate between Whoop and the US Food and Drug Administration (FDA).
Last month, the agency told Whoop that its tracker is operating as a medical device, and must therefore get FDA certification. Whoop pushed back. "Blood Pressure Insights is a wellness feature, not a medical device," it said at the time. "It’s designed to help you understand how your body responds to daily life, not to diagnose or treat any condition.”
According to Bloomberg, Whoop has now spoken to the FDA again and told the agency it still has no plans to remove blood pressure monitoring. "We believe it is not within the FDA’s authority to regulate the product. We therefore do not intend to remove the app," Whoop told the FDA in an Aug. 4 letter that says it wants to have a "constructive dialogue with agency officials.”
The FDA previously told Whoop that it needed to take “prompt action to address any violations," and that "Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
The Whoop MG also offers a "Heart Screener" ECG function that can take readings from your wrist and detect signs of Atrial Fibrillation, a leading cause of stroke. It also provides Irregular Heart Rhythm Notifications, something that’s been on Apple Watches since 2018.
At launch, some Whoop MG units had “rare and isolated” issues where the tracker died. At the time, Whoop told PCMag the issues were "impacting a small number of members" and the reports did not "reflect the experience of the vast majority of our members.” Whoop provided replacement devices to those impacted.