FDA Warning to Whoop Sparks Debate Over Wellness vs. Medical Device Claims

The U.S. FDA has issued a warning letter to wearable tech company Whoop for marketing its blood pressure insights feature without regulatory approval. The wristband estimates blood pressure trends based on heart rate variability during sleep. While Whoop claims the feature supports general wellness and isn’t a medical device, the FDA argues blood pressure is inherently diagnostic and poses regulatory concerns. The agency cited prior meetings and correspondence with Whoop and emphasized that such metrics can’t be considered low-risk. This has ignited a broader debate among regulatory experts over when wellness tools cross into medical device territory. Critics argue that Whoop’s claims resemble medical-grade insights. Supporters cite the 21st Century Cures Act, which excludes wellness functions from device classification. The issue is especially relevant as wearable health tech expands. Meanwhile, companies like Aktiia are pursuing FDA clearance, recently receiving approval for the first cuffless, over-the-counter wrist-based blood pressure monitor.

22-07-2025