FDA Clears First OTC Cuffless Blood Pressure Monitor

The US Food and Drug Administration (FDA) has cleared the first over-the-counter cuffless blood pressure monitor, granting authorization in July 2025.

The device, called the Hilo Band and developed by Aktiia, uses an optical sensor to continuously track blood pressure from the wrist. While cuffless, the band requires periodic calibration with a traditional cuff, according to the FDA’s 510(k) summary.

Aktiia has already commercialized the Hilo Band in Europe, where it received CE mark approval in 2021. The company is now preparing for a US launch in 2026 following FDA clearance.

23-08-2025