With this latest clearance, the Corsano CardioWatch System now enables healthcare professionals and researchers to continuously monitor medically certified Sleep-Wake metrics alongside vital signs including heart rate, oxygen saturation (SpO₂), respiratory rate, skin temperature, blood pressure and activity.

Sleep is a fundamental physiological process and an important indicator of overall health. Changes in sleep duration, continuity, and sleep-wake patterns often precede or accompany deterioration in a wide range of medical conditions. By integrating Sleep-Wake assessment with continuous vital sign monitoring, clinicians gain a more comprehensive picture of a patient’s recovery, resilience, and physiological status.

A Valuable Addition for Clinical Care

In hospitals, long-term care facilities, and remote patient monitoring programs, Sleep-Wake metrics provide objective insight into patient rest and recovery without requiring additional sensors or disrupting the patient’s normal routine. Sleep disruption is frequently associated with pain, infection, delirium, medication effects, respiratory disorders, and prolonged recovery. Continuous monitoring enables healthcare professionals to observe trends over time and assess the impact of therapeutic interventions.

When interpreted together with continuously measured physiological parameters, Sleep-Wake information can support clinical decision-making by providing additional context around patient wellbeing and recovery.

Supporting the Next Generation of Clinical Trials

The newly cleared functionality also strengthens the Corsano CardioWatch System as a platform for decentralized and hybrid clinical trials.

Sleep quality and sleep-wake behaviour are increasingly recognised as clinically meaningful endpoints across numerous therapeutic areas, including cardiovascular disease, neurology, oncology, psychiatry, metabolic disorders, respiratory disease, chronic pain, and pharmaceutical development.

Researchers can now collect continuous, objective, medical-grade Sleep-Wake data simultaneously with vital signs throughout the study period using a single comfortable wrist-worn device. This reduces patient burden, improves compliance, and provides richer longitudinal datasets than traditional episodic assessments.

The integration of certified Sleep-Wake monitoring with continuous physiological measurements allows investigators to better understand treatment effects on overall patient health, daily functioning, recovery, and quality of life.

Expanding the Corsano Health Platform

“This FDA clearance represents another important milestone in our mission to provide healthcare professionals with continuous, clinically meaningful patient insights,” said Peter Stas, CEO of Corsano Health.

“Healthcare is moving beyond isolated spot measurements toward continuous monitoring of patient trends. Sleep is one of the body’s most important vital recovery processes. By combining FDA-cleared Sleep-Wake monitoring with continuous vital signs, the Corsano CardioWatch System provides clinicians and researchers with a broader understanding of patient physiology, supporting earlier recognition of changes in health status and generating higher-quality data for clinical research.”

The Corsano CardioWatch System is designed for continuous, comfortable long-term monitoring in hospitals, at home, and in clinical research environments. Its lightweight wrist-worn design enables patient-friendly data collection while integrating with healthcare IT systems and clinical workflows.

This latest FDA clearance further strengthens Corsano Health’s position as a leading provider of medical-grade wearable technology for continuous patient monitoring, remote patient management, and clinical research.