FDA approves Israeli co Biobeat's patch and watch

AI  photo: Shutterstock

The patch and watch is for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home.

Israeli medical device company Biobeat announced today that the US Food and Drug Administration (FDA) has granted a 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. Biobeat's advanced sensing and remote monitoring solutions for patients enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.

Biobeat founder and CEO Arik Ben Ishay said, "This is the first cuffless blood pressure solution to be cleared by the FDA- no more need for an inflating cuff. This clearance opens tremendous opportunities for remote monitoring of vital signs of patients and we are excited that we can now also offer this in the US market," continues Ben Ishay. Biobeat's products have already been CE marked and approved as medical devices in Europe and Israel."

Biobeat Chief Medical Officer Prof. Arik Eisenkraft said, "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, we will continue to work with the FDA to approve additional parameters for our devices."

Biobeat chairman Dr. Dan J. Gelvan said, "The promise of remote care for patients and the equally important continuum of care: connecting home-based, community and hospital care, will not happen without novel medical-grade sensors and we are proud to be the pioneers in this field."

Published by Globes, Israel business news - en.globes.co.il - on August 26, 2019

© Copyright of Globes Publisher Itonut (1983) Ltd. 2019

AI  photo: Shutterstock
AI photo: Shutterstock
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