Israel’s Biobeat has secured CE mark approval for its full artificial intelligence (AI) powered wearable remote patient monitoring platform.
The approval has been given for Biobeat’s wrist and chest-patch monitoring devices that offer precise and continuous monitoring for crucial patient vital signs.
The signs consist of blood oxygen saturation, respiratory rate, non-invasive cuffless blood pressure, pulse rate, pulse rate variability, mean arterial pressure, pulse pressure, stroke volume, cardiac output, cardiac index, systemic vascular resistance and skin temperature.
To automatically and continuously track 15 cardio-pulmonary vital signs, the devices utilise the company’s non-invasive reflective photoplethysmography technology.
Biobeat’s approved platform also comprises one-lead EKG for the chest monitor device.
The CE mark approval is also applicable for Biobeat’s wireless capabilities, including its advanced Gateway (hospital) connectivity tool, mobile app (home), and cloud-based web management platform for healthcare providers.
The wireless capabilities offer healthcare staff a continuous and scalable view of patient health and predictive patient deterioration alerts.
Biobeat CEO Arik Ben Ishay said: “We are proud to receive CE Mark for the full gamut of remote patient monitoring capabilities that our wearable wrist and chest monitors and AI-enabled patient management tools can provide.
“With this approval, we further our goal of improving care and elevating patient outcomes across the European healthcare continuum, which now includes the new care frontier: the home.”
By connecting a cloud-based patient management system, the company’s wireless solutions offer medical staff real-time data and alerts, thereby helping in the early identification of clinical deterioration.
The management platform consists of an integrated automated and customisable early warning score system, which features advanced health-AI-based algorithms that analyse aggregated patient data to detect deterioration more precisely and offer predictive analytics.
Biobeat’s wearable devices are also claimed to be the first devices to be FDA-cleared for cuffless non-invasive PPG-based blood pressure monitoring.