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News From the Food and Drug Administration
July 5, 2000

New System for Monitoring Intrapartum Fetal Oxygen Saturation

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JAMA. 2000;284(1):33. doi:10.1001/jama.284.1.33-JFD00005-2-1

The FDA has approved OxiFirst Fetal Oxygen Saturation Monitoring System (Mallinckrodt/Nellcor, Pleasanton, Calif), the first pulse oximeter for continuous monitoring of intrapartum fetal oxygen saturation (FSpO2). Use of the OxiFirst system is indicated as an adjunct to fetal heart rate (FHR) monitoring in the presence of a nonreassuring fetal heart rate pattern and for a singleton fetus in vertex presentation with a gestational age of at least 36 weeks. The system consists of an intrauterine sensor, a connecting cable, and a patient monitor.