FDA advisers consider what human trials of ‘artificial womb’ could look like for human infants


Important Takeaways:

  • FDA advisers discuss future of ‘artificial womb’ for human infants
  • Independent advisers to the U.S. Food and Drug Administration are meeting this week to discuss the regulations, ethics and possibilities of creating an artificial womb to increase the chances that extremely premature babies would survive — and without long-term health problems.
  • Although no such device has been tested in humans, similar ones have been used in a handful of cases to successfully develop animals
  • An artificial womb is not designed to replace a pregnant person; it could not be used from conception until birth. Rather, it could be used to help a small number of infants born before 28 weeks of pregnancy, which is considered extreme prematurity.
  • “We believe that our preclinical data supports feasibility and safety and that it’s adequate for consideration of a carefully designed clinical study of artificial womb technology,” Flake told the committee.

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