Cloud-based SaMD (Software as a Medical Device) designed to help healthcare providers predict birth date using ultrasound images
denver, March 2, 2026 /PRNewswire/ — Ultrasonic AIThe company, a pioneer in artificial intelligence applications for medical imaging, today announced that it has received FDA De Novo clearance for its flagship delivery date AI technology. It is a cloud-based SaMD that determines predicted delivery dates (PDD) solely from standard ultrasound images and seamlessly integrates into current OB/MFM prenatal visit workflows. PDD is delivered in real time for actionable decision making by clinical teams.
The technology is trained on millions of anonymized ultrasound images across a variety of pregnancies and clinical settings and leverages an ensemble of deep learning neural networks to predict due date by analyzing the entire ultrasound image, including fetal and maternal features that correlate with birth timing. This technology is an adjunct tool designed to aid clinical decision-making in pregnancies where traditional identification, such as determining last menstrual period or gestational age by ultrasound, is unreliable. Turnaround AI complements clinical judgment by converting ultrasound image data into actionable insights that support personalized 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. “Deliver Date AI is not only innovative, but also a clinically evaluated tool that helps clinicians reduce uncertainty and better support mothers and families.”
Delivery AI has been evaluated in the peer-reviewed PAIR (Ultrasonic Perinatal Artificial Intelligence) study. Maternal-Fetal Medicine Journalconducted in collaboration with the University of Kentucky. A groundbreaking study of more than 5,700 patients demonstrated an impressive R² value of 0.92 accuracy in predicting days to delivery using only standard ultrasound images. An image-first approach supports equitable care across diverse populations and clinical settings.
“Fetal development and the timing of delivery influence nearly every decision in obstetrics,” said Dr. Nathan Fox, board-certified obstetrician-gynecologist, maternal-fetal medicine specialist, and partner physician at Ultrasound AI. “Date of Birth AI provides clinicians with unprecedented insight into the progression of pregnancy, allowing them to make more informed decisions about how and when to intervene. This technology has transformative implications for maternal and fetal healthcare.”
Turnaround time AI is compatible with most existing ultrasound equipment, can be installed in minutes, and results are available seconds after image upload. With minimal onboarding and no workflow disruption, this technology is scalable across high-volume health care systems, resource-constrained clinics, and desert obstetrics, while offering the potential to reduce downstream costs associated with preterm birth.
With FDA approval, Delivery Date AI is now available to clinics, hospitals, imaging centers, and ultrasound equipment partners across the United States. The FDA’s decision can be found on its website here.
Learn more about Ultrasound AI and Delivery Date AI. ultrasound.ai.
About ultrasound AI
Ultrasound AI builds image-specific artificial intelligence that provides 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 here ultrasound.ai.
media contact
[email protected]
Source Ultrasonic AI
