Israeli firm ChroniSense Medical’s Polso remote patient monitoring (RPM) device has received 510(k) clearance from the US Food & Drug Administration (FDA) for monitoring blood oxygen saturation (SpO₂), pulse rate and respiration rate.

“FDA clearance is a significant milestone towards the commercialisation of Polso Connect and towards creating a new model in chronic care management,” said ChroniSense Medical CEO Bridget Ross. “With six out of ten adults in the USA living with a chronic condition, and over $1.1tn in direct healthcare costs annually, there is a serious need for easy-to-use, medical grade, remote patient monitoring.”

Polso delivers on this promise by combining a medical grade, wrist-worn, vital sign monitor with a mobile app for patients and a cloud-based platform for clinicians that monitors in-life patient data, making Polso suitable for use in RPM and decentralised clinical trials.

ChroniSense Medical, a portfolio company of Rainbow Medical, is continuing its clinical development in collaboration with hospitals, partners and practitioners in the USA and globally. Recent validation studies demonstrated Polso’s accuracy and ease of use across demographic groups, and under-served patient populations. Additional vital sign monitoring parameters – including blood pressure via IP-protected radial artery signal acquisition – are in development.

“FDA clearance is an important validation of our technology,” said Din Hadass, ChroniSense medical general manager. “ChroniSense Medical is laser-focused on bringing to market monitoring that will revolutionise patient management, help save lives, and reduce the heavy cost burden of chronic care.”

ChroniSense Medical is working to transform chronic care management by developing a remote patient monitoring platform based on the company’s signal processing and data science capabilities. Polso Connect comprises a multi-sensor wireless wrist monitor, mobile application and cloud-based platform. It delivers medical grade, multiple vital sign monitoring capabilities for clinicians and patients. The technology platform is building a foundation for future AI-based predictive insights.