FDA clears wearable device to better monitor patients

The Food and Drug Administration has approved new wearable technology that offers non-invasive cuffless monitoring of blood pressure, oxygenation and heart rate.

The device, made by Biobeat, can be used in hospitals, clinics, long-term care settings and in a patient’s home.

The product, which received FDA 510 clearance, includes a smartwatch displaying heath metrics and a patch that can be placed anywhere on the upper torso to gather additional health metrics.

The wearable devices also offer continuous monitoring with real-time alerts and trend analysis.


“This is the first cuffless blood pressure solution to be cleared by the FDA,” says Arik Ben Ashay, founder of Biobeat, the Tel AVIV, Israel company that developed the product. “There’s no more need for an inflating cuff,” he adds. This clearance opens tremendous opportunities for remote monitoring of vital signs.”

The company, a start-up with 15 employees and approved in Europe and Israel, will continue to work with FDA to get approval of additional parameters for its devices.

Biobeat’s technology is based on reflective photoplethysmography, or PPG, an optical technique that measures blood volume changes in the microvascular bed of tissue used to non-invasively make measurements at the skin surface.

“Though we currently have two configurations—a wrist watch and a patch—Biobeat’s sensor can be adapted to any type of measurement and lifestyle configuration,” says Chief Medical Officer Arik Eisenkraft, MD. “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.”