Biobeat’s smartwatch and patch.

The FDA has granted a 510K clearance for Biobeat’s patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. According to press release, Biobeat’s products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.

The press release states that Biobeat’s smartwatch and patch connect to the cloud through either a smartphone or a dedicated gateway. The user will use one or the other device; whereas the watch is worn on the wrist the patch is to be placed anywhere on the upper torso.

Arik Ben Ishay, founder and CEO of Biobeat, says: “This is the first cuffless blood pressure solution to be cleared by the FDA—no more need for an inflating cuff. 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.”

Biobeat’s chief medical officer Arik Eisenkraft comments: “Remote monitoring of patient’s vital sign requires completely different technological approaches than current practice. 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.”

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