Butterfly Network has received FDA clearance for a fully automated Gestational Age (GA) Tool integrated into its handheld ultrasound platform, marking the first approved AI-powered blind-sweep ultrasound solution for estimating gestational age. The technology addresses a critical gap in maternal care, where timely and accurate pregnancy dating is often limited—especially in rural U.S. regions and low- and middle-income countries, where access to ultrasound and trained specialists is scarce.
The GA Tool uses a deep learning–based blind-sweep method to estimate gestational age in under two minutes through a simple three-step process: entering fundal height, applying gel, and performing guided probe sweeps. Unlike traditional ultrasound workflows, the system eliminates the need for image capture, manual interpretation, or fetal biometric measurements, reducing variability and enabling use by non-specialist providers. The model was trained on more than 21 million ultrasound images and delivers results comparable to sonographer-performed assessments for pregnancies between 16 and 37 weeks.
The tool is designed to support a range of clinical scenarios, including emergency care when gestational age is unknown, expanded access in underserved regions, and improved prenatal care in rural U.S. communities where patients may otherwise face long travel times for imaging. By enabling earlier and more accurate assessment, the technology can help guide prenatal screening, detect complications sooner, and improve outcomes for both mothers and infants.
Butterfly has already deployed the solution in Malawi and Uganda, supported in part by funding from the Gates Foundation, and plans to expand access further following FDA clearance. The launch aligns with broader efforts to improve maternal health outcomes globally and increase access to essential diagnostic tools in resource-limited settings.
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