Sam Brusco, Associate Editor12.06.22
ChroniSense Medical has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance for its Polso remote patient monitoring solution with initial indications of monitoring of blood oxygen saturation, 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," ChroniSense Medical CEO Bridget Ross told the press. "With 6 out of 10 adults in the US living with a chronic condition, and over $1.1 trillion in direct healthcare costs annually, there is a serious need for an easy-to-use , medical grade, remote patient monitoring solution."
Polso combines a medical-grade, wrist-worn vital signs monitor with a mobile app for patients and cloud-based platform for clinicians to monitor in-life patient data. It can be helpful for use in remote patient monitoring and decentralized clinical trial programs.
Additional vital sign monitoring parameters including blood pressure via IP-protected radial artery signal acquisition are in development, according to the company.
"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", said Din Hadass, ChroniSense Medical GM, Israel.
"FDA clearance is a significant milestone towards the commercialization of Polso CONNECT and towards creating a new model in chronic care management," ChroniSense Medical CEO Bridget Ross told the press. "With 6 out of 10 adults in the US living with a chronic condition, and over $1.1 trillion in direct healthcare costs annually, there is a serious need for an easy-to-use , medical grade, remote patient monitoring solution."
Polso combines a medical-grade, wrist-worn vital signs monitor with a mobile app for patients and cloud-based platform for clinicians to monitor in-life patient data. It can be helpful for use in remote patient monitoring and decentralized clinical trial programs.
Additional vital sign monitoring parameters including blood pressure via IP-protected radial artery signal acquisition are in development, according to the company.
"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", said Din Hadass, ChroniSense Medical GM, Israel.