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

Romi Littman
Business Development Manager


SOURCE Biobeat

These press releases may also interest you

at 07:50
SullivanCotter, the nation's leading independent consulting firm in the assessment and development of total rewards programs and workforce solutions for the health care industry and not-for-profit sector, welcomes new Principal, Amber Duncan. She...

at 07:45
Glooko, the global leader in diabetes data management, announced today that its Mountain View, California and Gothenburg, Sweden sites have received joint ISO 13485:2016 certification from accredited certification body Intertek Testing Services NA...

at 07:45
Dialogue, the leading Canadian telemedicine platform, today announces a groundbreaking partnership with Doctor On Demand, the leading virtual care provider in the United States. Through this partnership, enterprise clients will now have the option to...

at 07:35
Sage Therapeutics , a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced that it plans to advance SAGE-718, a novel,...

at 07:35
Biotia, a health tech company leveraging next-generation DNA sequencing (NGS) and artificial intelligence (AI) software for precision infectious disease detection and diagnosis, today announced an oversubscribed $2.4M seed raise and expanded...

at 07:35
Bristol-Myers Squibb Company today announced clinical results from the QUAZAR AML-001 study, evaluating investigational agent CC-486 as maintenance therapy in a broad population of patients with front-line, newly diagnosed acute myeloid leukemia...

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