Biobeat, an Israeli bio-medical technology firm, was granted FDA 501K clearance for its patch and smartwatch for blood pressure, oxygenation and heart rate monitoring in hospitals , clinics, and homes. Biobeat is a winner of the IOT / WT Innovation World Cup ® (Gore Innovation Center Award) and a WT Wearable Technologies Conference Series speaker and exhibitor.
“This is the FDA’s first cuffless blood pressure solution-no more need for an inflating cuff,” says Arik Ben Ishay, Biobeat’s founder and CEO. “This clearance opens up enormous opportunities for remote monitoring of patient’s vital signs and we are excited that we can now also deliver this in the US market,” Ben Ishay continues. Biobeat’s products have already been CE marked and approved as medical devices in Europe and Israel.
The smartwatch can be worn three days before a charge is required, while the patch is intended for up to 10 days of use. The firm says the patch can deliver the same vital signs as the watch.
“Remote monitoring of patient vital signs 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 working with the FDA to approve additional parameters for our devices,” continues Prof. Eisenkraft.
Dr. Dan J. Gelvan, Chairman of the Board said:
“The promise of remote patient care and the equally important continuum of care: connecting home, community and hospital care will not happen without new sensors of medical grade and we are proud to be the pioneers in this field.”
Founded in 2016, Biobeat aims to create wireless, medical-grade products that enable health care providers to treat patients outside their facilities as efficiently as they do on-site. Its products allow cloud-based healthcare to connect via a smartphone or a gateway dedicated to it. 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.