Biobeat stated on Monday that it has passed US Food and Drug Administration (FDA) 510K clearance for its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home.
The company added that the products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway. The smartwatch and patch connect to the cloud through either a smartphone or a dedicated gateway. The user will use one or the other device; whereas the watch is worn on the wrist the patch is to be placed anywhere on the upper torso.
Remote monitoring of patient's vital sign requires completely different technological approaches than current practice. While blood pressure, heart rate and oxygenation are the backbones of monitoring, the company will continue to work with the FDA to approve additional parameters for our devices, added says its CMO Prof. Arik Eisenkraft, MD.
Based in Israel, the company's sensors are based on the exceptional proprietary technologies in the field of reflective Plethysmography (PPG), developed by a team of world-renowned experts in this field. It is focusing on wireless medical-grade products that allow health providers to care as efficiently for patients outside of their facility as on-site.
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