CAS Medical Systems, Inc. (CASM) Granted FDA 510(k) Clearance to Expand Labeling for FORE-SIGHT Cerebral Oximeter
Today, CAS Medical Systems, Inc. announced a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its FORE-SIGHT(r) Cerebral Oximeter. The new labeling allows the Oximeter to be used on all patients, including those weighing less than 5.5 pounds. The FORE-SIGHT Cerebral Oximeter is a Near Infra-Red Spectroscopy (NIRS) based device designed to non-invasively and continuously detect oxygen saturation changes in brain tissue, enabling clinicians to quickly react to potentially harmful events before they become serious. According to the company, FORE-SIGHT is the first and only device that provides a non-trend, absolute measure…