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Home » ChroniSense Medical wins FDA clearance for wearable patient monitor

ChroniSense Medical wins FDA clearance for wearable patient monitor

December 7, 2022 By Sean Whooley

ChroniSense Medical Polso watch remote patient monitor
The Polso remote patient monitor. [Image courtesy of ChroniSense Medical]
ChroniSense Medical announced that its Polso remote patient monitoring system received FDA 510(k) clearance.

Polso received initial indications for monitoring blood oxygen saturation (SpO2), pulse rate and respiration rate.

Yokneam, Israel-based ChroniSense designed Polso to combine a monitor, mobile app and cloud-based platform. The medical-grade, wrist-worn vital sign monitor pairs with a mobile app for patients. The cloud-based platform for clinicians monitors in-life patient data.

“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 six out of 10 adults in the U.S. 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.”

ChroniSense, a Rainbow Medical portfolio company, collaborates with hospitals, partners and practitioners in the U.S. and globally. Recent validation studies demonstrated accuracy and ease of use with Polso. That ranged across demographic groups and underserved patient populations.

The company has additional vital sign monitoring parameters under development. That includes blood pressure via IP-protected radial artery signal acquisition.

“FDA clearance is an important validation of our technology,” said Din Hadass, ChroniSense Medical GM, Israel. “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.”

Filed Under: 510(k), Business/Financial News, Digital Health, Food & Drug Administration (FDA), Health Technology, Patient Monitoring, Regulatory/Compliance, Software / IT Tagged With: ChroniSense

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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