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FDA clears CASMED FORE-SIGHT Oximeter

The US Food and Drug Administration (FDA) has cleared CAS Medical Systems' (CASMED) FORE-SIGHT Oximeter for use on neonatal abdomen.

The FORE-SIGHT Oximeter is designed to determine oxygen saturation of the abdomen of certain newborn babies.

CAS Medical Systems president and CEO Thomas Patton said after many years of clinical study, they 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," Patton said.

"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 in the second quarter of 2012.