CAS Medical Systems (CASM) Receives FDA Clearance to Expand Labeling for its FORE-SIGHT Cerebral Oximeter
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CAS Medical Systems, Inc. (Nasdaq: CASM) 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 FORE-SIGHT to be used on all patients, including those weighing less than 2.5 Kilograms (kg).
The FORE-SIGHT Cerebral Oximeter is a Near Infra-Red Spectroscopy (NIRS) based device that non-invasively and continuously detects oxygen saturation changes in brain tissue, allowing clinicians to quickly react to reverse potentially harmful events before they become critical. FORE-SIGHT is the first and only device on the market today that provides a non-trend, absolute measure of cerebral tissue oxygen saturation for all patient populations regardless of age and weight. [SM]
The FORE-SIGHT Cerebral Oximeter is a Near Infra-Red Spectroscopy (NIRS) based device that non-invasively and continuously detects oxygen saturation changes in brain tissue, allowing clinicians to quickly react to reverse potentially harmful events before they become critical. FORE-SIGHT is the first and only device on the market today that provides a non-trend, absolute measure of cerebral tissue oxygen saturation for all patient populations regardless of age and weight. [SM]
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