Ornim announces FDA market approval for non-invasive brain oximetry and blood flow monitoring


Ornim announced FDA’s clearance 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.

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 personalise patient treatment while potentially decreasing the overall costs associated with factors such as length of hospitalisation 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 optimise the physiologic variables for an individual patient, at a particular time, and guide management,” said Daryl Gress, University of Virginia Health System in Charlottesville, USA.

“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.