Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that its wearable remote patient monitoring device have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate.
The company’s wireless wrist and chest monitoring devices, the first-ever to receive FDA clearance for cuffless blood pressure monitoring from PPG only, can support health teams by transmitting real-time patient data.
“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,” said Arik Ben Ishay, CEO of Biobeat. “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.”
“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.” Said Prof. Arik Eisenkraft, VP of Clinical and Regulation. “Our platform now provides the five fundamental parameters that nurses are required to collect from patients, whether in the hospital or at home.”
The company’s medical grade wearable monitors utilize proprietary non-invasive reflective photoplethysmography monitoring technology to automatically and continuously track multiple vital signs and health parameters. The wireless solutions connect to a cloud-based patient management system to provide medical staff with real-time data and alerts, enabling early identification of clinical deterioration. The management platform includes an integrated automated, customizable early warning score system and incorporates advanced health-AI-based algorithms that analyze aggregated patient data to identify deterioration more accurately and provide predictive analytics.
The company’s hospital and long-term care monitoring solutions are currently used in dozens of medical centers and facilities across the globe.