CAS Medical Systems, Inc. (CASMED), received US FDA 510(K) approval for expanding the labeling of its FORE-SIGHT Cerebral Oximeter. The new labeling increases the FORE-SIGHT use to the patients, including those with weight less than 2.5 Kilograms.
This Near Infra-Red Spectroscopy (NIRS) based device allows non-invasively and continuously to detect oxygen saturation changes in brain tissue. It will help to quickly act upon to reverse potentially harmful events before they become critical. FORE-SIGHT provides a non-trend, absolute measure of cerebral tissue oxygen saturation for all patient.
We currently use the FORE-SIGHT Cerebral Oximeter for clinical monitoring of term and near-term infants pre-ECMO and or on ECMO, as well as infants with hypoxic-ischemic encephalopathy requiring cooling treatment for neuro-protection. Use of the FORE-SIGHT Cerebral Oximeter for patients below 2.5 kg will allow for clinical monitoring of smaller neonates potentially at risk for intra-ventricular hemorrhage, central apnea, and seizures, commented Dr. K. Rais-Bahrami, Director of the Neonatal-Perinatal Fellowship Program at Children’s National Medical Center in Washington, DC.
Andrew E. Kersey, President and Chief Executive Officer of CASMED, stated: We are pleased with the FDA’s decision to expand clearance for the FORE-SIGHT Cerebral Oximeter to include patients below 2.5 kg. This expanded labeling will allow us additional access into the Neonatal ICU market, where a large percentage of at-risk patients have a low or very low birth weight. In conjunction with the unique benefits that the FORE-SIGHT small sensor offers, including COOL-LIGHT technology that protects fragile skin from heat, non-adhesive sensor solutions, and a very small sensor footprint, the new, expanded labeling uniquely positions CASMED for acceptance in the Neonatal arena.