FDA Warns Against Smartwatch Blood Pressure Apps As HHS Pushes Wearables

By Cara Smith / September 18, 2025 at 6:14 PM

FDA this week issued a broad warning that consumers should not use unauthorized, over-the-counter smartwatches and smart ring apps to measure blood pressure, saying the apps fall outside the agency’s definition of “wellness” products and must be approved as devices due to safety risks.


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