The bio-medical technology company, Biobeat has announced that the U.S. Food and Drug Administration has granted a 510K clearance for its wearable watch and patch for non-invasive cuffless monitoring of blood pressure in hospitals, clinics, long-term care and at home. The product will be able to have cloud-based 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 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. CE has already approved this product of Biobeat similar to many other 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.