Cardiology FDA Cleared

FDA clears Biobeat’s cuffless BP wearable

Patient-monitoring startup Biobeat said today that the FDA has cleared its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home.

The Tel Aviv, 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 FDA — no more need for an inflating cuff,” said Biobeat CEO Arik Ben Ishay in a news release. “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 U.S. market.”

Biobeat’s products have already been CE-marked and approved as medical devices in Europe and Israel.

“Remote monitoring of patient’s vital signs requires completely different technological approaches than current practice,” said 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.”

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