Ultrasound AI receives FDA De Novo clearance for delivery date AI technology

(Press-News.org) Ultrasound AI, a pioneer in artificial intelligence applications for medical imaging, today announced it has received FDA De Novo clearance for its flagship Delivery Date AI technology, a cloud-based SaMD that determines a Predicted Delivery Date (PDD) solely from standard ultrasound images and seamless integration into current OB/MFM prenatal visit workflows; PDD is provided in real-time for actionable decision-making by the clinical team.

 

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.”

 

Delivery Date AI has been evaluated in a peer-reviewed PAIR (Perinatal Artificial Intelligence in Ultrasound) Study, published in The Journal of Maternal-Fetal & Neonatal Medicine, conducted in collaboration with the University of Kentucky. The landmark study of more than 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.

 

“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.”

 

Delivery Date AI is compatible with most existing ultrasound machines, can be installed in minutes, and delivers results in seconds after image upload. With minimal onboarding and no workflow disruption, the technology is scalable across high-volume health systems, resource-constrained clinics, and obstetric deserts, while offering the potential to reduce downstream costs associated with preterm birth.

 

With FDA clearance, Delivery Date AI is now available to practices, hospitals, imaging centers, and ultrasound equipment partners across the United States. The FDA decision is available on their website here.

 

To learn more about Ultrasound AI and Delivery Date AI, please visit ultrasound.ai.

 

About Ultrasound AI

Ultrasound AI builds image-only artificial intelligence that augments clinicians with earlier, more accurate insights. The company's patented technology predicts delivery timing from standard ultrasound images and is designed to fit seamlessly into existing ultrasound workflows. The company is exploring additional obstetric applications through ongoing research. Learn more at ultrasound.ai.

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