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The Food and Drug Administration (FDA) posted a new warning for patients and providers to be aware of risks related to unauthorized devices that claim to measure or estimate blood pressure. Many blood pressure devices currently sold directly to consumers have not been evaluated for safety and effectiveness. Such devices are required to receive FDA marketing authorization to be lawfully marketed in the United States. With the rise in wearables, more consumers are looking to smartwatches, rings, and other high-tech devices to gauge their health and wellness. And while some products have verified efficacy, the market is full of devices that might claim to measure biometrics without evidence of their performance integrity. Faulty readings could lead to unnecessary anxiety, testing, and additional costs.
How to know: To see if a blood pressure device has been evaluated and authorized by the agency, search the 510(k) database using the device name. Devices that have been evaluated and authorized will generally have the product code DXN. Additionally, FDA recommends that providers assist patients in choosing appropriate devices. Anyone can voluntarily report an issue with a device on the FDA website.