FDA Approves WHOOP’s Updated Blood Pressure Analysis Approach
Photo: Android Authority
Quick answer
The FDA has approved WHOOP’s updated blood pressure analysis feature in its wearables, allowing the company to avoid classification as a medical device by revising app terminology.
The U.S. Food and Drug Administration (FDA) has approved WHOOP’s revised approach to blood pressure analysis in its wearable devices. The decision concludes nearly a year of negotiations between the regulator and the manufacturer, which began after the FDA raised concerns about the feature in the WHOOP MG device.
Initially, the FDA believed that blood pressure analysis could classify the device as a medical device, requiring additional oversight. WHOOP defended its feature by agreeing to modify app terminology. Instead of indicating 'normal' or 'elevated' blood pressure, the device now provides users with 'health insights,' avoiding direct medical recommendations.
WHOOP does not measure blood pressure directly—users must first calibrate the system using a traditional blood pressure monitor. After calibration, the device tracks changes based on its sensor data. The WHOOP MG is available only as part of the 'Life' subscription, starting at $359 per year.
The FDA’s decision removes the threat of a full ban on the feature, which could have impacted the device’s popularity among health-conscious users. In the future, similar technologies may emerge in alternative apps like Goose, expanding access to such solutions.
Common questions
- Why did the FDA intervene in WHOOP’s operations?
- The FDA expressed concerns that WHOOP’s blood pressure analysis feature could classify the device as a medical device, requiring strict regulatory compliance. The company addressed these concerns by adjusting app wording to avoid medical claims.
- How does WHOOP measure blood pressure without a cuff?
- WHOOP does not measure blood pressure directly. Users must first calibrate the system using a traditional blood pressure monitor, after which the device tracks changes based on its sensor data.
- What changes did WHOOP make to comply with FDA requirements?
- The company removed references to 'normal' or 'elevated' blood pressure, replacing them with general health insights. This adjustment helped avoid legal risks associated with medical claims.
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