Corsano Health Receives FDA Clearance

Corsano Health is announcing that its CardioWatch 287-2 System received FDA Clearance.

The Hague, March 22, 2024 – Corsano Health, a leading MedTech company that creates, manufactures, and sells advanced real-time remote patient monitoring solutions, for use in clinical research and patient care, today announced US Food and Drug Administration (FDA) 510(k) clearance for its CardioWatch 287-2 System.

The Corsano CardioWatch 287-2 System is a Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years old and over), a web-based browser platform and a user mobile application operable in either Patient Mode or HealthCare Professional (HCP) Mode.

Vital signs data both on mobile devices and web-based dashboard are available to the HealthCare Provider only.

The Corsano Bracelet is intended to continuously monitor physiological vital sign data: Pulse Rate (PR), oxygen saturation (SpO2), skin temperature (sTEMP) and activity (STEPS) and for intermittent monitoring of respiratory rate (RR) from the person being monitored and securely transmit the encrypted data via the Patient User App to the secure server.

The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.

The Corsano CardioWatch 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of: non-invasive blood pressure (NIBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as continuous monitoring of axillary temperature (aTEMP).

"This achievement is a major milestone for Corsano Health in its mission to provide Continuous Patient Monitoring, Anytime, Anywhere." said Drs. Peter Stas, CEO of Corsano Health. 

Corsano’s vital signs algorithms, derived from real-world patient data, have been rigorously tested and validated against gold standards.

“We take pride in creating the Corsano CardioWatch Solution, delivering a proven and reliable digital health system that accelerates clinical trials and generates unparalleled insights to develop life-saving therapies faster.”

Corsano Cardiowatch 287-2 Bracelet