FDA Reviewers Have Concerns About Artificial Womb Trials in Humans

September 19, 2023

(Med Page Today) – FDA staff raised concerns that need to be addressed prior to potential human tests of artificial womb technology (AWT), a device that simulates a womb for extremely premature infants, as detailed in briefing documents released ahead of a Pediatric Advisory Committee meeting next week.

AWT devices are intended to treat extremely premature infants, who have increased risks of mortality and morbidity — especially those born at less than 28 weeks’ gestation. The current standard of care involves treatments related to respiratory care, cardiovascular support, thermoregulation, nutrition, and neurodevelopmental impairment in the neonatal intensive care unit (NICU). (Read More)