FDAnews
www.fdanews.com/articles/210767-opticyte-monitor-gets-breakthrough-device-status-for-detecting-risk-of-organ-failure

Opticyte Monitor Gets Breakthrough Device Status for Detecting Risk of Organ Failure

January 11, 2023

Opticyte has received Breakthrough Device status for its Cell O2 Patient Monitor for continuous monitoring of patients at risk of organ failure.

The monitor uses optical spectroscopy β€” which measures the absorption and emission of light β€” to detect low oxygen levels within cells.

The device can replace pulse oximeters to measure oxygen levels of sepsis, trauma and cardiac surgery patients who are β€œon the verge of organ failure,” the company says.

The Breakthrough Devices program allows for an expedited reviews of devices that could potentially provide more effective treatment compared to the standard-of-care for life-threatening diseases.

View today's stories