The FDA recently issued a warning letter to Whoop over its Blood Pressure Insights feature, arguing that even an estimated BP reading—calibrated via a cuff and based on overnight HRV and heart‑rate data—crosses into medical device territory and needs formal clearance. Whoop insists this remains a wellness feature (not a diagnostic tool), citing the 21st Century Cures Act. The Verge story delves into how the line between “just wellness” and regulated medical tech is blurring—and why the distinction matters for consumer safety and innovation. Read more at https://www.theverge.com/health/715102/dangerously-blurry-line-between-wellness-and-medical-tech