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WHOOP, There It Is: Lessons From WHOOP’s FDA Warning Letter

WHOOP, There It Is: Lessons From WHOOP’s FDA Warning Letter

She has covered the evolution of the WHOOP/US Food and Drug Administration (FDA) regulatory conflict since it began and shares her reflections here. In July 2025, the fitness wearable company WHOOP received a warning letter from the FDA [3] for their “Blood Pressure Insights” (BPI) feature, noting that it was clearly a medical device requiring proper 510 K clearance. For anyone following the wearables space, this wasn’t surprising.

Blythe Karow, JMIR Correspondent

J Med Internet Res 2026;28:e90882