FDA clears first cuffless solution for measuring blood pressure
Food and Drug Administration has cleared it's first cuffless device for measuring blood pressure.
U.S. Food and Drug Administration (FDA) has granted a 510K clearance for a patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home.
The clearance has been granted to Biobeat, a bio-medical technology company that developed advanced sensing and remote monitoring solutions for patients. Biobeat's products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.
The Israel-based company’s technology is based on reflective photoplethysmography (PPG). Its devices use several LED sources, wavelengths and proprietary algorithms to receive the PPG signal free of background noise, according to the company’s website. Healthcare providers can obtain patient information through an app or a dedicated gateway.
The watch may be worn for three days before needing a charge, while the patch designed for a single use of up to 10 days. The patch can provide the same vital signs as the watch and also has a single-lead ECG for placement over the upper left chest wall, according to the company.
This is the first cuffless blood pressure solution to be cleared by the Food and Drug Administration—no more news 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.