Le Lézard
Classified in: Health
Subject: FDA

First-ever: FDA Clears Biobeat's Wearable Watch and Patch for Non-invasive Cuffless Monitoring of Blood Pressure


TEL AVIV, Israel, Aug. 26, 2019 /PRNewswire/ -- Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced today that the U.S. 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 products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway. 

Biobeat's 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.

"This is the first cuffless blood pressure solution to be cleared by the FDA?no more need for an inflating cuff," says Arik Ben Ishay, Founder and CEO of Biobeat. "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.

"Remote monitoring of patient's vital sign requires completely different technological approaches than current practice," says Biobeat's Chief Medical Officer Prof. 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," continues Prof. Eisenkraft. 

"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," says Dr. Dan J. Gelvan, Chairman of the Board.

About Biobeat

Biobeat is a revenue-stage company located in Israel. The company employs 15 employees and has initiated sales in Israel and Europe. Biobeat's sensors are based on the company's exceptional proprietary technologies in the field of reflective Plethysmography (PPG), developed by a team of world-renowned experts in this field. The company is focusing on wireless medical-grade products that allow health providers to care as efficiently for patients outside of their facility as on-site.

You can find more information at our website: www.biobeat.cloud 

Pictures of device: Here

Contacts:
Romi Littman
Business Development Manager
romi@bio-beat.com

 

SOURCE Biobeat


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News published on 26 august 2019 at 09:00 and distributed by: