Postmarket Surveillance Needed For Mallinckrodt OxiSure, FDA Panel Says
This article was originally published in The Gray Sheet
Executive Summary
Mallinckrodt should conduct postmarket surveillance of caesarean-section rates at sites using the firm's OxiSure fetal oxygen saturation monitor as a condition of FDA approval, the agency's Obstetrics and Gynecology Devices Panel concluded Jan. 24.
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