WHOOP wins FDA sign-off for blood pressure labeling changes

WHOOP received FDA approval earlier this week to continue offering its blood pressure analysis tool after adopting labeling changes, according to Bloomberg. The FDA had first contacted WHOOP in August 2025 with concerns about how the feature was presented on the company’s wearable.

The dispute centered on WHOOP MG, with MG meaning Medical Grade, and its blood pressure analysis feature. Android Authority reported last summer that the FDA was concerned the feature could bring the wearable under closer medical device scrutiny in the United States.

WHOOP did not disable blood pressure support after the FDA raised its concerns in August 2025. Bloomberg reported that WHOOP challenged the agency’s position at the time, and the two sides then worked for about 10 months on a mutually acceptable solution that ended with revised labeling.

Related questions

• When did the FDA first raise concerns about WHOOP’s blood pressure analysis?
• What changes did WHOOP make to keep its blood pressure tool available?
• Did WHOOP remove blood pressure support during the FDA review?