ChroniSense Medical Ltd. took a step towards its vision of transforming chronic care management with Polso™, the company’s Remote Patient Monitoring (RPM) solution, achieving 510(k) clearance from the U.S. Food and Drug Administration (FDA). Initial indications include monitoring of blood oxygen saturation (SpO2), pulse rate and respiration rate
“FDA clearance is a significant milestone towards the commercialization of Polso CONNECT™ and towards creating a new model in chronic care management,” said ChroniSense Medical CEO, Bridget Ross. “With 6 out of 10 adults in the US living with a chronic condition, and over $1.1 trillion in direct healthcare costs annually1, there is a serious need for an easy-to-use , medical grade, remote patient monitoring solution.”
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™ ideal for use in RPM and Decentralized Clinical Trials (DCT) programs.
ChroniSense Medical, a portfolio company of Rainbow Medical, is continuing its clinical development in collaboration with leading hospitals, partners, and expert practitioners in the U.S., and globally. Recent validation studies demonstrated Polso™ 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. ChroniSense Medical is laser-focused on bringing to market monitoring solutions that will revolutionize patient management, help save lives, and reduce the heavy cost burden of chronic care”, says Din Hadass, ChroniSense Medical GM, Israel.
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