FDA

FDA warns against unauthorized blood pressure devices

September 19, 2025

FDA has issued a safety communication warning against the use of unauthorized devices – particularly OTC products and wearable tech – that claim to measure or estimate blood pressure. These devices, including smartwatches and smart rings, often lack FDA marketing authorization, meaning their safety and effectiveness haven't been evaluated.

Inaccurate readings from such devices can lead to missed or delayed diagnoses of hypertension or hypotension, resulting in serious complications like stroke, heart failure, kidney damage, and early death. Because hypertension is frequently asymptomatic, reliable measurements are essential for timely intervention.

FDA urges clinicians to guide patients toward FDA-authorized devices, identifiable via the 510(k) database under product code DXN. Physicians should also counsel patients on the risks of relying on unregulated technology for blood pressure monitoring, especially when clinical decisions depend on accurate data.

Source:

(2025, September 16). FDA. Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety Communication. https://www.fda.gov/medical-devices/safety-communications/do-not-use-unauthorized-devices-measuring-blood-pressure-fda-safety-communication