Biobeat Nabs FDA Clearance For Its Wearable Blood Pressure Monitors
Israeli MedTech company Biobeat announced on Monday that it received 501K clearance from the US Food and Drug Administration (FDA) for its smart and wearable wristwatch and patch that monitor blood pressure.
The wearable devices measure blood pressure, oxygenation, and heart rate and can be used in hospitals, clinics, for long-term care, or at home. The products enable remote, non-invasive and medical-grade accurate monitoring of numerous vital signs and other significant physiological parameters, the company said.
Biobeat has already received a CE mark in Europe.
“This is the first cuffless blood pressure solution to be cleared by the FDA—no more need for an inflating cuff,” said 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.”
The watch can be worn for three days before needing a charge, while the patch is designed for use of up to 10 days. The company says the patch can provide the same vital signs as the watch.
Founded in 2016, the central Israel-based company aims to create medical-grade sensors to provide remote care. Its products enable cloud-based healthcare with connectivity through a smartphone or dedicated gateway.
The products rely on reflective photoplethysmography (PPG), a non-invasive optical technique that uses light to estimate physical parameters of cardiovascular and respiratory systems.
“We are proud to be the pioneers in this field,” said Dr. Dan J. Gelvan, chairman of the board.