FETAL PULSE OXIMETER COMPANIES SUGGEST CLINICAL ENDPOINTS TO FDA OB/GYN PANEL; MAJORITY OF PANEL MEMBERS FAVOR REDUCTION IN RATE OF CESAREAN SECTIONS
This article was originally published in The Gray Sheet
Executive SummaryCesarean section (CS) rate reduction is an appropriate efficacy measurement in clinical trials of fetal pulse oximeters for use in intrapartum fetal assessment, a majority of FDA's Obstetrics and Gynecology Devices Panel concluded at its July 22 meeting in Gaithersburg, Maryland.
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