Trained on millions of de-identified ultrasound images across diverse pregnancies and clinical settings, the technology leverages an ensemble of deep-learning neural networks to analyze entire ultrasound images, including fetal and maternal characteristics correlated with delivery timing, to forecast a Predicted Delivery Date. The technology is an adjunctive tool designed to aid clinical decision-making in pregnancies where traditional dating, including last menstrual period and/or ultrasound gestational-age dating, are unreliable. Delivery Date AI complements clinical judgment by turning ultrasound imaging data into actionable insights that support individualized care planning and follow up.

“Today’s FDA De Novo clearance represents a major milestone in our mission to reduce the burden of preterm birth by supporting earlier, more informed clinical decision-making,” said Robert Bunn, President and Founder of Ultrasound AI. “Delivery Date AI isn’t just innovative; it’s a clinically evaluated tool that helps clinicians reduce uncertainty and better support mothers and families.”