CAS Medical Systems, Inc. (CASM) said it obtained clearance from the U.S. Food and Drug Administration, or FDA, to market its FORE-SIGHT Oximeter to determine oxygen saturation of the abdomen of certain newborn babies.
The company's Small Sensor is now indicated for monitoring the absolute regional hemoglobin oxygen saturation of the abdomen of infants weighing less than four kilograms.
Thomas Patton, president and chief executive officer, said, "We are proud to have the first tissue oximeter with a specific abdominal claim to be cleared by the FDA. After many years of clinical study, we were able to develop a specific FORE-SIGHT algorithm for the monitoring of the newborn abdomen with a high degree of accuracy. Given a newborn's unique physiology, a custom algorithm was necessary to provide accurate quantitative tissue oximetry values. We believe these new and specific indications will aid clinicians in their care of babies and in the expansion of the applications for tissue oximetry monitoring of newborns."
The company expects that FORE-SIGHT Absolute Tissue Oximeters with the new neonatal abdomen capability will be available to the market in the second quarter of 2012.
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