North America

Cuffless blood pressure, oxygenation, heart rate monitor receives 510(k) clearance

Biobeat's connected remote monitoring device is currently available as either a wristwatch or an adhesive patch.
By Dave Muoio
11:45 am

Tel Aviv, Israel-based Biobeat has been granted 510(k) clearance for a remote monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate.

Designed for use in the hospital or at home, the device is available as either a wristwatch or adhesive patch. Of particular note, the products differentiate themselves from other remote monitoring devices through a photoplethysmography (PPG) approach that that sidesteps the need for an inflatable cuff.

"This is the first cuffless blood pressure solution to be cleared by the FDA — no more need for an inflating cuff," Arik Ben Ishay, founder and CEO of Biobeat, said in a statement. "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 products are designed to transmit their readings through either a smartphone or another dedicated gateway set up by an organization. The company also notes on its website that the technology could also be applied to other form factors such as ear plugs.


Remote monitoring technologies such as Biobeat’s are becoming more popular among providers and patients alike, due in part to their potential to improve compliance, comfort and patient outcomes.

These remote monitoring technologies are also powering “hospital at home” movement, an  opportunity to limit expensive hospital stays while keeping patients happily with their loved ones. Then, should the conditions of those post-acute patients take a turn for the worse, remote monitoring platforms help to promptly reconnect them to professional care.

The clearance of Biobeat’s technology offers another option for providers and patients interested in exploring these approaches, especially if they’re looking to avoid the inconvenience of an inflatable cuff.

"Remote monitoring of patient's vital sign requires completely different technological approaches than current practice," Dr. Arik Eisenkraft, Biobeat’s CMO, said in a statement. "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.”


Earlier this year Scottish startup Current Health (formerly snap40) landed FDA clearance for an AI-enabled vital sign monitor, both in the inpatient and outpatient setting. Meanwhile, Sentinel Healthcare closed a $2 million round to continue work on its connected blood pressure cuff, as Bardy Diagnostics raised $35.5 million for its vitals monitoring patch.


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