Biobeat has received 510(k) approval from the US Food and Drug Administration (FDA) for its wearable remote patient monitoring (RPM) platform to measure additional vital signs.
The Israeli medical device maker has been offering a disposable short-term chest-monitor and a long-term wrist-monitor, as part of its health-AI platform.
With the current regulatory approval, its wireless wrist and chest monitoring devices can now measure respiratory rate and body temperature, in addition to cuffless blood pressure, blood oxygen saturation and pulse rate.
The company’s RPM health-AI platform is designed to measure 13 parameters consisting of cuffless blood pressure, pulse rate, respiratory rate, blood oxygen saturation, temperature, stroke volume, cardiac output, and one lead ECG, among others.
Biobeat CEO Arik Ben Ishay said: “This additional FDA clearance milestone cements Biobeat as the market leader within the remote patient monitoring space and allows us to take the next step in increasing our market presence.
“We are confident that our remote patient monitoring solution is a superior solution for the US healthcare market and we are excited to expand our operation and continue providing care teams with an accurate and reliable patient monitoring system.”
Biobeat leverages non-invasive photoplethysmography (PPG) sensor technology for its remote monitoring platform, to track multiple vital signs and health parameters.
Its wearable wrist and chest monitoring platform was the first to receive FDA approval for cuffless blood pressure monitoring using PPG only technology in 2019.
The wireless solutions are integrated with a cloud-based patient management system to enable real-time data and alerts, and early diagnosis of worsening clinical conditions.
The cloud-based solution includes an automated, and customisable early warning score system, and leverages advanced health-AI-based algorithms to analyse the patient data.
The company said that its hospital and long-term care monitoring solutions are currently being used in various medical centres and facilities worldwide.
Biobeat clinical and regulation VP Arik Eisenkraft said: “With the FDA clearance for these additional parameters, healthcare providers using Biobeat’s solutions can rest assured that they are receiving timely patient health data that they can rely upon to provide improved level of care, even from a distance.
“Our platform now provides the five fundamental parameters that nurses are required to collect from patients, whether in the hospital or at home.”
