Butterfly wins FDA clearance for automated gestational-age ultrasound AI tool

Reuters03-30
Butterfly wins FDA clearance for automated gestational-age ultrasound AI tool
  • Butterfly Network received FDA clearance for fully automated gestational age tool integrated into its handheld ultrasound system.
  • Clearance covers first FDA-cleared blind-sweep ultrasound AI tool for estimating gestational age.
  • Tool delivers estimate in under two minutes via Butterfly app for pregnancies between 16-37 weeks.
  • Deployment in Malawi and Uganda supported in part by Gates Foundation grant.


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