Israeli biotech company Biobeat has secured a 510A clearance from the US Food and Drug Administration (FDA) for its wearable watch and patch for monitoring blood pressure (BP), oxygenation, and heart rate in clinics, hospitals, long term care and at home.
The user will have to use one or the other device, while the watch is worn on the wrist the patch is to be put anywhere on the upper torso.
According to Biobeat, its products offer cloud-based healthcare with connectivity by means of a smartphone or a dedicated gateway.
Arik Ben Ishay – Founder and CEO of Biobeat said: “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.”
The company says that its products are CE marked and are approved as medical devices across Israel and Europe.
Arik Eisenkraft – Biobeat Chief Medical Officer said: “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 says that its sensors are based on its technologies in the field of reflective Plethysmography (PPG). The Israeli biotech company is focused on wireless medical-grade products that are said to help health providers to care as efficiently for patients outside of their facility as on-site.