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Biobeat RPM Devices and Platform Receive FDA Clearances for Stroke Volume and Cardiac Output

Updated: Aug 20

Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that its wearable remote patient monitoring devices have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to monitor stroke volume and cardiac output in addition to cuffless blood pressure, blood oxygen saturation, pulse rate, respiratory rate and body temperature.

Biobeat's remote patient monitoring devices are the first-ever to receive FDA clearance for cuffless blood pressure monitoring from photoplethysmography (PPG) only. The company's cloud-based platform is designed to support health teams by transmitting real-time patient data and facilitating patient-physician interactions.

"The additional FDA clearances to monitor stroke volume and cardiac output represent our ongoing efforts to provide innovative and reliable clinical solutions to clinicians and patients in both at-home and in-hospital settings," said Arik Ben Ishay, Founder and CEO of Biobeat. "This milestone is a further validation of our proprietary non-invasive reflective PPG monitoring platform, which is already in use across a number of clinical networks in the U.S."

"Our devices are now FDA-cleared to monitor a total of seven health metrics including the five vital signs, which all medical practitioners are required to assess regardless of healthcare settings," said Prof. Arik Eisenkraft, VP of Clinical and Regulation at Biobeat. "With these additional clearances for stroke volume and cardiac output, we expect to further equip clinicians with the necessary tools to provide fast and accurate detection that can lead to timely actionable results for patients with cardiac disease, whose needs remain severely overlooked."

About Biobeat

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.

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