Despite the FDA’s requests to remove the blood pressure tracking tool in Whoop’s new fitness tracker, the company has stated that it will not comply, as the use case is “non-medical.”
According to a new report from Bloomberg, the FDA recently sent a warning letter to Whoop, noting that the addition of the company’s new blood pressure tracking tool would mean the Whoop 5.0 would now be classified as a medical device. A device for which Whoop has not gone through the proper channels to certify as such.
Blood pressure insights is a tool that offers daily readings to assist in recovery, sleep, and stress. The app uses algorithms and AI to determine health trends, and the device is widely considered one of the best-performing on the market, though it has no interactive display.
The report notes that the FDA threatened Whoop with regulatory action, which could include seizure and civil penalties unless the company went through the proper process for registering a product with the Food and Drug Administration. The company stated that it “believe[s] it is not within the FDA’s authority to regulate the product.”
Whoop claims that the Whoop 5.0 is not a medical device, since it isn’t used for diagnosing or treating medical conditions. This is something fitness trackers aim to get around by offering disclaimers when setting a device up and explaining new features. According to the FDA, that isn’t enough.
Blood pressure tracking is something the Galaxy Watch series is capable of, though it doesn’t seem to be under pressure from the regulatory body. Both the Whoop 5.0 and Galaxy Watch series offer a similar disclaimer. The following is from Whoop:
Blood Pressure Insights is not a medical device and cannot diagnose or manage medical conditions. It does not provide medical advice. Always consult your doctor for health concerns and never delay or modify medical care based on its information.
The request by the FDA for Whoop to register its device as a “medical device” might set a precedent for other fitness trackers in the industry. Warnings and disclaimers might not be enough for certain features as sensors get more advanced and closer in performance to registered medical devices.
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