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”.