The US Food and Drug Administration (FDA) has approved CAS Medical Systems (CASMED) to market its Fore-Sight oximeter, designed to determine oxygen saturation of the abdomen of certain newborn babies.
The absolute tissue oximeter is used in critical care settings to monitor the oxygenation of the brain and other tissue, helping physicians to treat patients with dangerously low levels of cerebral oxygen often associated with serious injury to multiple organs.
CASMED president and CEO Thomas Patton said after many years of clinical studies, they were able to develop a specific fore-sight algorithm for the monitoring of the newborn abdomen with a high degree of accuracy.
"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," Patton added.
Children’s National Medical Center in Washington, US, Neonatal Perinatal Fellowship Program director Rais-Bahrami said clinicians now have a non-invasive and reliable monitoring solution which provides absolute oximetry values to guide clinical intervention for vulnerable preterm infants.
"Our data confirmed the accuracy of the fore-sight values compared to the invasive reference and showed a standard deviation of just +/- 5%," Bahrami added.
"The ability of a non-invasive monitor to provide this level of quantitative accuracy is a meaningful milestone in the advancement of tissue oximetry as a critical tool in the care of newborns."
Fore-sight absolute tissue oximeters with the new neonatal abdomen capability are expected to be available in the second quarter of this year, 2012, according to the company. CASMED is a developer and manufacturer of medical devices, including bedside patient vital signs monitors, proprietary non-invasive blood pressure measurement technology and neonatal intensive care supplies.
Image: Fore-sight absolute tissue oximeter of CAS Medical Systems has been cleared by the FDA. Credit: FDA.