The FDA has granted Biobeat, an Israeli firm, clearance for the company’s wrist watch and patch that measure blood oxygenation, heart rate, and blood pressure. Not relying on a traditional cuff allows for long-term monitoring of blood pressure, particularly in patients who have difficulty keeping track of their health parameters on their own. Moreover, it can help to identify abnormal blood pressure in situations when a cuff-based meter is not appropriate or simply unavailable.
“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 Biobeat devices are intended for use in clinics, hospitals, long-term care facilities, as well as by independent patients at home.
The underlying technology within the Biobeat devices is based on reflective plethysmography, an optical technique that is normally used to detect blood volume changes within tissues. A number of LED light sources emit various wavelengths of light into the tissue, while an algorithm analyzes the reflected light that returns. Thanks to the new signal processing system that the team built, they can effectively clean out most of the background noise in the signal and obtain the relevant data hiding within.
Product page: Biobeat Wrist Watch and Patch