Today, CAS Medical Systems, Inc. announced a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its FORE-SIGHT(r) Cerebral Oximeter. The new labeling allows the Oximeter to be used on all patients, including those weighing less than 5.5 pounds.
The FORE-SIGHT Cerebral Oximeter is a Near Infra-Red Spectroscopy (NIRS) based device designed to non-invasively and continuously detect oxygen saturation changes in brain tissue, enabling clinicians to quickly react to potentially harmful events before they become serious. According to the company, FORE-SIGHT is the first and only device that provides a non-trend, absolute measure of cerebral tissue oxygen saturation for all patient populations regardless of age and weight.
“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,” stated 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, added, “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(tm) 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.”