Artificial Womb Technology Not Yet Ready for Human Trials Adcomm Says

Much needs to be hammered out before the FDA can comfortably green light first-in-human studies of artificial womb devices for extremely premature infants, said several members of the FDA’s Pediatric Advisory Committee (PAC) on Tuesday.

After spending the day hearing from experts and considering what kind of data scientists will have to show in such trials as well as what kind of regulations may be required, the committee wrapped up saying they’d like to see more studies focusing on animals and have more questions answered before the technology is tested in humans.

Artificial womb technology (AWT) aims to bridge the period between extreme preterm birth and later gestation to allow for organ maturation in a system that mimics the womb environment with artificial amniotic fluid and an artificial placenta that provides circulation and oxygenation for medication and nutrient delivery, as well as gas exchange.

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