What is the FDA's warning about blood pressure devices?

The FDA has warned that many blood pressure measuring devices, including features on smartwatches and smart rings, are not authorized for medical use. These devices have not been evaluated for safety and effectiveness.

What are the risks of using unauthorized blood pressure devices?

The risks include inaccurate readings, failure to detect important changes in blood pressure, delays in seeking necessary medical treatment, and potential for inappropriate medication changes.

How can I check if a blood pressure device is FDA-authorized?

You can check the FDA's 510(k) database online by searching for the device's name. A 510(k) clearance indicates the FDA has determined the device can be legally marketed as safe and effective.

Should I stop using my smartwatch to monitor my blood pressure?

The FDA's warning specifically targets unauthorized devices. If your smartwatch or smart ring feature has not been cleared by the FDA, it should not be relied upon for medical decisions. Always consult with a healthcare professional.

FDA Warns On Inaccurate BP Devices

Agency Issues Urgent Warning Amid Wearable Tech Boom

The FDA has issued a stark warning. It cautions against using many blood pressure devices on the market. The agency says these devices lack proper marketing authorization. This includes popular features on smartwatches and smart rings.

“Do not use unauthorized blood pressure devices,” the FDA stated. The agency has not evaluated its safety or effectiveness. This warning applies to many over-the-counter products. The FDA advises consumers to use only authorized devices.

Using unapproved devices carries serious risks. They may miss crucial changes in blood pressure. This could delay necessary medical treatment. Inaccurate readings could also lead to incorrect medication changes. Alerts from these devices might be wrong. This could cause unnecessary medical interventions.

The warning follows the FDA’s clearance of a new feature for the Apple Watch. This feature detects signs of hypertension. It analyzes data collected over 30 days. It then alerts the user to seek further assessment.

Consumers can verify a device’s status. They should check the FDA’s 510(k) database. A 510(k) clearance means the device is safe and effective. It is also substantially equivalent to a legally marketed device.

Healthcare providers must also take action. The FDA suggests they counsel patients. They should help them choose an authorized blood pressure device. Even with FDA authorization, many devices lack independent validation. Hypertension specialists recommend checking validatebp.org for a list of proven monitors.