FDA Approves Wearable Devices for The Patients

FDA Approves Wearable Devices for The Patients

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

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

The product, which received FDA 510 approval, includes a smartwatch displaying health metrics and a patch that may be placed anywhere on the upper torso to gather further health metrics. The wearable devices also supply continuous monitoring with real-time alerts and trend analysis.

Arik Ben Ashay, the founder of Biobeat, stated that This is the first cuffless blood pressure solution to be cleared by the FDA. The Tel Aviv, Israel company that manufactures the product. “There’s no requirement for a cuff,” he replies. This approval opens tremendous opportunities for remote monitoring of vital signs.”

The company, a start-up with 15 staff and authorized in Europe and Israel, will proceed to work with the FDA to get the approval of further parameters for its devices.

Biobeat’s technology is based on reflective photoplethysmography, an optical method that measures blood volume differences in the microvascular area of tissue used to make measurements on the skin surface non-invasively.

Chief Medical Officer Arik Eisenkraft, MD. Stated that Though they currently have two configurations, a wristwatch and a patch Biobeat’s sensor may be adapted to any measurement and lifestyle configuration. While blood pressure, heart rate, and oxygenation are the backbones of monitoring, they are going to continue to work with the FDA to approve extra parameters for our devices.