FDA grants CASMED 510(k) clearance for expanded labeling of FORE-SIGHT Absolute Tissue Oximeter

CAS Medical Systems, Inc. (Nasdaq:CASM) today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded labeling of its FORE-SIGHT® Absolute Tissue Oximeter to monitor skeletal muscle of infants, children and adolescents weighing between 5 and 50 kg.

The FORE-SIGHT Absolute Tissue Oximeter is used for the continuous, non-invasive monitoring of oxygen saturation of blood in the brain of patients in critical situations. FORE-SIGHT provides highly accurate absolute measurement of  oxygenation levels which allows clinicians to take immediate corrective action when those levels become dangerously low. With this FDA cleared indication, FORE-SIGHT can now be clinically utilized for use on both brain and skeletal muscle.

The addition of non-cerebral monitoring represents a critical step in the evolution of this innovative technology. "The expanded application of skeletal muscle to our indications for use will allow improved monitoring of critically ill patients. This monitoring can aid clinicians to quickly detect ischemic threats, such as those associated with anemia, low-cardiac output or shock," stated Thomas M. Patton, President and CEO of CASMED. 

"Cerebral and skeletal muscle oximetry with FORE-SIGHT can provide an important adjunct to conventional monitoring that allows for continuous, non-invasive and earlier assessment of perfusion abnormalities," Mr. Patton added.  "Because  patient care and innovation are core values of CASMED, we are excited about the opportunities that this new application will offer the medical community and for the expanded application of our FORE-SIGHT technology."