Delivery Date AI
AI-powered delivery date prediction from standard ultrasound imaging for pregnancies without reliable dating
Company profile
Company profile
Ultrasound AI is a medical AI company that has developed Delivery Date AI™, an FDA De Novo-granted cloud-based Software as a Medical Device (SaMD) designed to support obstetric care through AI-powered delivery date prediction. The company's flagship product analyzes standard pregnancy ultrasound images to provide clinicians with an independent Predicted Delivery Date (PDD) for singleton pregnancies between 14 0/7 and 36 6/7 weeks gestation where a reliable estimated delivery date is unavailable. Founded by Robert Bunn, the company was built on the principle that every family deserves clarity and confidence during pregnancy. Delivery Date AI addresses a critical gap in prenatal care: approximately 24.5% of US pregnancies do not begin prenatal care in the first trimester, and 35% of US counties are maternity care deserts. The technology has been clinically validated across more than 5,700 patients in peer-reviewed studies, demonstrating a 58% reduction in prediction error compared to standard of care methods. The solution integrates seamlessly into existing clinical workflows, requiring no new hardware and delivering results in under 30 seconds through a HIPAA-compliant cloud infrastructure. Ultrasound AI's technology is designed as an adjunctive tool to support clinical judgment, not replace it, providing OB/GYNs and MFM specialists with an additional reliable data point when standard dating methods fall short due to unreliable last menstrual period, absence of first-trimester scans, or late presentation to care.
Company description Ultrasound AI official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas deployment with recorded integration context.
Recorded integration context: Compatible with most standard ultrasound systems, DICOM image upload.
Company milestones
FDA De Novo authorization granted March 2026. Expanded U.S. commercial deployment preparation underway. Multiple media features in 2026 including CBS News Colorado, The Healthcast, and The Healthtech Podcast.
Partnerships
02 · Flagship portfolio
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AI-powered delivery date prediction from standard ultrasound imaging for pregnancies without reliable dating
03 · Research intelligence
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Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians · Dec 1, 2025
Clinical validation
No linked records are currently available.
Regulatory
DEN250007 · De Novo · Feb 11, 2026
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Compared to standard of care Hadlock method in suboptimally dated singleton pregnancies
FDA Pivotal Validation Study with 247 patients
When due date was less certain (18.07% vs 13.25%, p=0.01, N=2,113, JMIR Pediatrics & Parenting, Reis et al. 2020)
Using AI technology to determine delivery dates and assess pregnancy risks, helping solve problems before they arise
Institution feels confident using the technology as it helps solve problems before they arise and is described as 'saving lives'
Clinical study for suboptimally dated singleton pregnancies between 14-36 weeks gestation
58% reduction in prediction error compared to standard of care (15.22 days mean absolute error vs 36.41 days using Hadlock method, p < 0.001)
Independent clinical validation study of AI-powered delivery date prediction accuracy
5,714 patients studied across 19,940 ultrasound exams demonstrating clinical validation
05 · Leadership
Leadership profiles and professional links from the current Company record.
Robert Bunn
President & Founder
06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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