Whoop is Not Removing This 'Dangerous' Feature
The saga between Whoop and the FDA shows no signs of coming to an end soon. Following a warning from the federal agency, Whoop has refused to remove or modify its Blood Pressure Insights feature from its screen-free wearable, the Whoop MG.
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FDA vs. Whoop: The Clash Over Blood Pressure Insights
Last month, Whoop caught the attention of the FDA after the agency flagged its new Blood Pressure Insights tool, which was launched with the Whoop MG (review), as a medical device. The feature provides systolic and diastolic readings and estimates, which the FDA says require formal approval or certification before being made available to the public.
The FDA argues that blood pressure is a critical health metric in wearables, and inaccurate readings could pose serious risks. High blood pressure is linked to conditions such as hypertension, hypotension, and cardiac arrest, making it dangerous for users who rely on these readings to guide medication or treatment decisions.
Whoop, however, maintains that Blood Pressure Insights is a “general wellness” feature. The company claims that it is intended to inform users, not diagnose or treat medical conditions.
Whoop Refuses to Remove the Feature
In a recent statement to Bloomberg, the FDA reiterated that it “has not authorized BPI for any use, including for the measurement or estimation of a user’s blood pressure” in the Whoop MG. The agency’s deadline for compliance has passed, but Whoop is standing firm.
The outlet obtained a letter sent by Whoop to the FDA dated August 4, in which the company stated it “believes it is not within the FDA’s authority to regulate the product” and that the agency has “misinterpreted” the nature of the Blood Pressure Insights tool. Whoop insists the feature does not violate FDA regulations and continues to offer it to users.
The Boston-based wearable maker has also requested a meeting with the FDA to clarify its position. However, it remains unclear how the agency will respond or what resolution might follow.
What’s Next for Whoop MG?
Currently, the Blood Pressure Insights tool is available with the Whoop MG as part of the Whoop Life plan, which costs $359 per year. Alongside this feature, Whoop has also introduced an ECG with Atrial Fibrillation (Afib) detection, but this one has received FDA clearance.
For now, it seems a resolution is still a long way off. However, when it arrives, it could help define the regulatory boundaries for wellness tools in wearable devices.
Do you think Whoop is right to keep the feature in its wearable? Share your thoughts in the comments.
Source: Bloomberg
