FDA clears Ornim CerOx 3210F monitor
Ornim has received the US Food and Drug Administration (FDA)510(k) clearance to market its CerOx 3210F monitor for non-invasive brain oximetry and blood flow monitoring.
The CerOx 3210F device uses 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.
University of Virginia Health System in Charlottesville Daryl Gress said a non-invasive device that can provide both oximetry and flow data will bring neuromonitoring to a new level and these parameters will enable the intensivist to optimize the physiologic variables for an individual patient, at a particular time, and guide management.
Ornim CEO Yitzhak Zilberman said they are pleased with the FDA's decision and Ornim is able to market the only non-invasive monitor displaying both oximetry and flowmetry information.
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