Biobeat hits vital five with latest FDA green light

Biobeat's wearable remote patient monitoring platform is now approved in the US for tracking five fundamental vital signs, after having picked up 510(k) clearances for respiratory rate and body temperature. The system is already cleared for monitoring blood pressure; blood oxygenation saturation; and pulse rate. 

The Israeli company's platform includes wrist and chest monitoring devices for continuously collecting vital health parameters from patients at home or in the hospital; the former is designed for long-term repeated use, while the chest monitoring patch is meant to be a disposable product, designed for single patient use to avoid transmission of diseases. In August 2019, the system was the first ever to be FDA cleared for cuffless blood pressure monitoring from photoplethysmography (PPG) only, the underlying sensing technology deployed in the devices. 

CEO Arik Ben Ishay commented that "with a total of five vital signs cleared by the FDA, including cuffless blood pressure, blood oxygen saturation, pulse rate, respiratory rate, and body temperature, we are confident that [Biobeat's] remote patient monitoring solution is a superior solution for the US healthcare market."

Broader CE mark

Biobeat's wearable devices are designed to capture and monitor more than these five vital signs. In May 2021, the firm got the go-ahead to CE mark its wrist and chest monitors for tracking 12 health parameters: blood oxygen saturation, respiratory rate, blood pressure, pulse rate, pulse rate variability, mean arterial pressure, pulse pressure, stroke volume, cardiac output, cardiac index, systemic vascular resistance and skin temperature. The chest patch also has a one-lead EKG feature.

The CE mark also covered Biobeat's other wireless capabilities, which include its proprietary Gateway (hospital) connectivity tool, home-use mobile app, and cloud-based web management platform for healthcare providers, which provide healthcare staff with a continuous, scalable view of patient health and predictive patient deterioration alerts.

Petah Tikva-based Biobeat anticipates the FDA clearance to accelerate international commercialisation of its system.