Ultrasound AI has received FDA De Novo clearance for its Delivery Date AI technology – a cloud-based software that predicts delivery dates from standard ultrasound images alone, without relying on last menstrual period dating or traditional gestational age estimates. The company says it’s the first tool of its kind to receive this classification.
The technology uses an ensemble of deep-learning neural networks trained on millions of de-identified ultrasound images to analyze both fetal and maternal characteristics correlated with delivery timing. It’s designed as an adjunctive tool for pregnancies where traditional dating methods are unreliable, delivering a predicted delivery date in real time during standard prenatal visits.
A peer-reviewed study of more than 5,700 patients, published in The Journal of Maternal-Fetal & Neonatal Medicine in collaboration with the University of Kentucky, demonstrated an R-squared value of 0.92 in predicting days to delivery using only ultrasound images.
“Delivery Date AI isn’t just innovative; it’s a clinically evaluated tool that helps clinicians reduce uncertainty and better support mothers and families,” said Robert Bunn, president and founder of Ultrasound AI.
“Delivery Date AI gives clinicians unprecedented insight into a pregnancy’s progression, allowing us to make more informed decisions for how and when we intervene,” added Dr. Nathan Fox, a board-certified MFM specialist and partner physician with Ultrasound AI.
The practical angle is worth noting: the software is compatible with most existing ultrasound machines, installs in minutes, and delivers results in seconds – making it potentially scalable across everything from high-volume health systems to resource-constrained clinics and obstetric deserts. Given that preterm birth is a leading cause of neonatal morbidity and carries significant downstream healthcare costs, earlier and more accurate delivery timing predictions could have meaningful implications for care planning and intervention decisions.
Delivery Date AI is now available to practices, hospitals, and imaging centers across the U.S.
