FDA clearance allows the wearable device to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate.
Petah Tikva, Israel-based Biobeat’s wireless wrist and chest monitoring devices became the first of their kind to receive FDA clearance for cuffless blood pressure monitoring from photoplethysmography (PPG) only in 2019. The platform can support health teams by transmitting real-time patient data, according to a news release.
The system uses proprietary, non-invasive reflective PPG monitoring technology to automatically and continuously track multiple vital signs and health parameters. It connects to a cloud-based patient management system that provides real-time data and alerts.
Biobeat’s system includes an automated, customizable early warning score system and uses artificial intelligence (AI)-based algorithms that analyze aggregated patient data to identify deterioration more accurately and provide predictive analytics.
“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,” Biobeat CEO Arik Ben Ishay said in the release. “With a total of 5 vital signs cleared by the FDA, including cuffless blood pressure, blood oxygen saturation, pulse rate, respiratory rate, and body temperature, 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.”