FDA to Review New Fetal Monitoring System

ST. LOUIS, Jan. 14 -- Mallinckrodt Inc. reported that its pre-market approval (PMA) application for a new infrared-based fetal oxygen saturation monitoring system called OxiSure has been accepted for filing by the US Food and Drug Administration. An advisory panel will review the application later this month and make a recommendation to the FDA as to whether the application should be approved.
Mallinckrodt's Oxisure system was designed to allow obstetricians to measure directly the arterial oxygenation of a fetus during labor and delivery. Using technology derived from the company's pulse oximeters, the system consists of a non-invasive fetal sensor containing red and IR light sources connected to a monitor that displays the percentage of oxygen in the fetal blood in real time.