Butterfly Network’s gestational age (GA) tool has secured US Food and Drug Administration (FDA) clearance, making the point-of-care ultrasound (POCUS) specialist the first company to receive US market approval for a tool to estimate GA.
Integrated into Butterfly’s handheld ultrasound system, the company’s tool uses an artificial intelligence (AI)-based ‘blind-sweep’ method to deliver a GA estimate in under two minutes. According to Butterfly, the tool has been trained on more than 21 million images across diverse patient demographics and care settings, allowing it to deliver “consistent results in patients between 16-37 weeks that are equivalent to sonographer-performed, biometry-based gestational age assessments”.
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Butterfly also highlighted that its GA tool is designed to minimise user variability and provide swift results by removing the need for image capture, interpretation, or foetal biometric measurements.
Already being deployed in Malawi and Uganda due to an initiative made possible in part by a grant from the Gates Foundation, Butterfly said that FDA clearance will enable it to expedite rollouts of its POCUS featuring the GA tool across additional regions in sub-Saharan Africa and also the US.
Steve Cashman, Butterfly’s chief business officer, commented: “The GA tool is built to address three critical use cases: enabling faster decisions in emergency settings when gestational age is unknown; expanding access in countries where maternal and neonatal mortality remains high; and improving prenatal ultrasound access in rural US communities, where patients may otherwise travel hours for.
“Ultimately, it’s about helping clinicians act faster, earlier, and with greater confidence, at critical moments and in any setting.”
GA is the standard measurement of how far along a pregnancy is, and helps clinicians to time key prenatal screenings, detect complications sooner, guide intervention, and improve outcomes for mothers and babies.
However, for communities facing socioeconomic barriers and a lack of access to basic obstetric imaging protocols, this metric can be difficult to establish. Research indicates that in the US, almost half of rural areas lack hospital obstetric services. Meanwhile, 92% of maternal and neonatal deaths globally occur in low- and middle-income countries – many of which could be prevented with access to basic imaging and earlier intervention.
