Ultrasound AI, a company focused on artificial intelligence (AI) applications for medical imaging, has received U.S. Food and Drug Administration (FDA) De Novo clearance for its flagship Delivery Date AI technology.

The cloud-based software-as-a-medical-device (SaMD) determines a predicted delivery date (PDD) from standard ultrasound images and integration into current OB/MFM prenatal visit workflows. PDD is offered in real-time for actionable decision-making by the clinical team.

Delivery Date AI was trained on millions of de-identified ultrasound images across diverse pregnancies and clinical settings. It leverages deep-learning neural networks to analyze entire ultrasound images, including fetal and maternal characteristics correlated with delivery timing, to forecast a Predicted Delivery Date.

It’s an adjunctive tool to aid clinical decisions in pregnancies where traditional dating like last menstrual period and/or ultrasound gestational age-dating are unreliable. Delivery Date AI complements clinical judgment by transforming 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.”

The landmark PAIR (Perinatal Artificial Intelligence in Ultrasound) study of over 5,700 patients demonstrated remarkable accuracy of 0.92 R² value in predicting days to delivery using only standard ultrasound images. The image-first approach supports equitable care across diverse populations and clinical settings.

Delivery Date AI is compatible with most existing ultrasounds, the company said. It can be installed in minutes and provides results in seconds after image upload.

“Fetal development and delivery timing impact nearly every decision in obstetrics,” said Dr. Nathan Fox, board-certified OBGYN, Maternal Fetal Medicine specialist, and partner physician with 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. This technology has transformative implications for maternal and fetal healthcare.”