FDA Approves Expanded Use For Medical Monitor

Ornim Inc. has received clearance from the U.S. Food and Drug Administration to market its oximetry and blood flow monitor, the Santa Clarita-based medical device company announced. The clearance allows the device to now be marketed as a non-invasive monitor of blood flow in tissue for adults. Previously, it only had clearance for non-invasive monitoring of regional hemoglobin oxygen saturation in the brain or skeletal muscle. The company is calling its CerOx 3210F monitor 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. “With over 20 percent annual growth in the oximetry monitoring market alone, the clinical demand is clear,” said Yitzhak Zilberman, CEO of Ornim Inc. “Moreover, the clinical community is sending us clear signal that the 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.” Ornim Inc. is a privately held medical device start-up company founded in 2004. Its research and development subsidiary, Or-Nim Medical Ltd., is located in Lod, Israel. Jessica Vernabe