Sam Brusco, Associate Editor03.28.22
Wearable remote monitoring firm Biobeat has received U.S. Food and Drug Administration (FDA) 510(k) clearance 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 were the first to receive FDA clearance for cuffless blood pressure monitoring from only PPG.
"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," Arik Ben Ishay, CEO of Biobeat told the press. "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 U.S. 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 at Biobeat. "Our platform now provides the five fundamental parameters that nurses are required to collect from patients, whether in the hospital or at home."
Biobeat’s wearable monitors use non-invasive PPG monitoring to automatically, continuously track multiple vital signs and health parameters. They connect to a cloud-based patient management system for real-time data and alerts for early identification of clinical deterioration.
The management tool also features an automated, customizable early earning score system. Health-AI-based algorithms analyze aggregated data to spot deterioration more accurately and offer predictive analytics.
The company’s wireless wrist and chest monitoring devices were the first to receive FDA clearance for cuffless blood pressure monitoring from only PPG.
"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," Arik Ben Ishay, CEO of Biobeat told the press. "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 U.S. 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 at Biobeat. "Our platform now provides the five fundamental parameters that nurses are required to collect from patients, whether in the hospital or at home."
Biobeat’s wearable monitors use non-invasive PPG monitoring to automatically, continuously track multiple vital signs and health parameters. They connect to a cloud-based patient management system for real-time data and alerts for early identification of clinical deterioration.
The management tool also features an automated, customizable early earning score system. Health-AI-based algorithms analyze aggregated data to spot deterioration more accurately and offer predictive analytics.