FDA Clears the Biobeat Remote Patient Monitoring Device and Platform for Additional Vital Signs
PETAH TIKVA, Israel, March 28, 2022 /PRNewswire/ -- 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. Biobeat'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 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 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.
Biobeat's hospital and long-term care monitoring solutions are currently used in dozens of medical centers and facilities across the globe.
Biobeat is a med-tech company with unique health-AI capabilities in the patient monitoring space. The company's remote patient monitoring (RPM) health-AI platform includes a disposable short-term chest-monitor and a long-term wrist-monitor, both of which utilize a photoplethysmography-based (PPG) sensor to continuously provide accurate patient readings of 13 health parameters, including cuffless blood pressure, pulse rate, respiratory rate, blood oxygen saturation, temperature, stroke volume, cardiac output, one lead ECG (only chest-monitor) and more. Leveraging its automatic, continuous and noninvasive AI based RPM platform, Biobeat has generated the biggest vital-sign database in the world, which it utilizes to identify early deterioration of patients via its proprietary big-data and health-AI tools.
Aggregated patient health data is viewed by medical staff via Biobeat's secure HIPAA and GDPR compliant cloud-based patient management platform. The platform includes an automated real-time early warning score (EWS) system that incorporates advanced AI-based algorithms to provide alerts on patient health status and potential deterioration. These capabilities allow Biobeat to support medical teams with tailored patient care such as adjustment of therapeutics and early prevention of specific disease exacerbations. Biobeat's wearable devices are the first to be FDA-Cleared for cuffless non-invasive blood pressure monitoring and are also CE Mark certified. Founded in 2016, Biobeat is headquartered in Petah Tikva, Israel.
For more information, visit: https://www.bio-beat.com/.
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