Advocacy
Unauthorized blood-pressure wearables
On September 16, 2025, FDA warned the public not to use unauthorized devices that claim to measure or estimate blood pressure — including software on smartwatches and smart rings sold over the counter. The agency has not reviewed those products for safety or effectiveness.
Wrong numbers, the communication says, can delay treatment of high or low blood pressure. High blood pressure often has no symptoms; the harm listed is stroke, heart attack, heart failure, kidney failure, cognitive decline, and early death. FDA’s instruction to patients is to search the 510(k) database and look for product code DXN. The products are not covered by the general-wellness policy, the agency writes, because they are not solely wellness uses and are not low risk.
This is the patient-facing form of the same fight as a warning letter: a claim that a gadget measures a vital sign, without the authorization that claim requires. The communication asks people who think they got a bad reading to file a MedWatch report. It does not name a brand. “Any unauthorized software features on wearables… regardless of brand.”
fda.gov — Do Not Use Unauthorized Devices for Measuring Blood Pressure — 09/16/2025
These notes paraphrase a public government record. They are not legal advice.