Ornim receives FDA 510(k) clearance for non-invasive monitoring of blood flow in tissue

Ornim, Inc. is pleased to announce the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CerOx 3210F monitor. Additionally to its previous clearance for non-invasive monitoring of regional hemoglobin oxygen saturation in the brain or skeletal muscle, the CerOx 3210F is now also intended for use as a non-invasive monitor of blood flow in tissue of adults.

“A non-invasive device that can provide both oximetry and flow data will bring neuromonitoring to a new level. These parameters will enable the intensivist to optimize the physiologic variables for an individual patient, at a particular time, and guide management”

The CerOx 3210F is currently the only device to use a single, non-invasive probe for simultaneously and independently measuring both oximetry and blood flow parameters, together providing a clear indication of tissue perfusion. The flow adds an important dimension in monitoring the tissue, helping personalize patient treatment while potentially decreasing the overall costs associated with factors such as length of hospitalization and stay in intensive care.

"A non-invasive device that can provide both oximetry and flow data will bring neuromonitoring to a new level. These parameters will enable the intensivist to optimize the physiologic variables for an individual patient, at a particular time, and guide management," noted Dr. Daryl Gress of the University of Virginia Health System in Charlottesville, VA.

"We are very pleased with the FDA's decision. Ornim is now able to market the only non-invasive monitor displaying both oximetry and flowmetry information. With over 20% annual growth in the oximetry monitoring market alone, the clinical demand is clear. Moreover, the clinical community is sending us clear signals that the added dimension of flow/perfusion may make a real difference in patient care. We are determined to respond to that by bringing CerOx to the market quickly and efficiently," stated Yitzhak Zilberman, CEO of Ornim, Inc.