TEL AVIV — Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced Monday 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 health care with connectivity either through a smartphone or a dedicated gateway.
“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 chief executive officer 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 Dr. Arik Eisenkraft. “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 Gelvan, chairman of the board.