FDA Okays Biobeat's Cuffless Blood Pressure Monitor

Patrice Wendling

August 28, 2019

Biobeat has received 501K clearance from the US Food and Drug Administration (FDA) for a smartwatch and patch to monitor blood pressure and other vital signs.

This is the first FDA approval of a blood pressure monitor that does not employ a traditional cuff, according to the Tel Aviv–based company.

The devices use photoplethysmography to noninvasively measure changes at the skin surface in blood pressure, heart rate, and oxygenation. The single-use patch also features a single-lead electrocardiogram that records when placed over the upper left chest wall.

The patch can be worn for 10 days; the watch has a battery life of 3 days when used continuously. Designed for long-term use in hospitals, clinics, and the home, the devices record and transmit data to a cloud-based server through a patient's smartphone or a dedicated gateway, the company says.

"Remote monitoring of patient's vital sign requires completely different technological approaches than current practice," Biobeat chief medical officer Arik Eisenkraft, MD, said. "While blood pressure, heart rate, and oxygenation are the backbones of monitoring, we will continue to work with the FDA to approve additional parameters for our devices."

Biobeats products are already CE marked and approved in Europe and Israel.

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