Delivery Date AI
Overview
Delivery Date AI™ is an FDA De Novo granted cloud-based AI technology authorized for clinical use in routine obstetric ultrasound. It provides a Predicted Delivery Date (PDD) solely from standard ultrasound images to aid clinical decision-making, particularly for singleton pregnancies between 14 0/7 and 36 6/7 weeks gestation where a reliable estimated delivery date (EDD) is unavailable. This novel Class II device with special controls offers AI-powered insights to improve delivery timing estimates, supporting clinicians and families by addressing the critical issue of inaccurate due dates and their associated risks, such as preterm births.
The technology is compatible with most existing ultrasound machines, with installation taking minutes and results delivered in seconds after image upload. It has been clinically validated in studies, demonstrating significant improvement in prediction accuracy compared to standard methods. Ultrasound AI aims to provide equitable care across diverse populations and clinical settings, including resource-constrained clinics and obstetric deserts.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- FDA De Novo Granted (Class II device)
- Cloud-based AI technology (SaMD)
- Determines Predicted Delivery Date (PDD)
- Analyzes standard ultrasound images
- Indicated for singleton pregnancies (14 0/7 to 36 6/7 weeks gestation)
- Supports cases without a reliable Estimated Delivery Date (EDD)
- Aids clinical decision-making
- Provides AI-powered insights from ultrasound
- Compatible with most existing ultrasound machines
- Results delivered in under 30 seconds after upload
Use Cases
- Providing a Predicted Delivery Date (PDD) when a reliable EDD is unavailable
- Supporting clinicians in obstetric care for improved delivery timing estimates
- Enhancing confidence for expectant mothers regarding due dates
- Addressing the clinical challenges and risks associated with inaccurate pregnancy dating
- Seamless integration into current OB/MFM prenatal visit workflows
- Scalable for high-volume health systems, resource-constrained clinics, and obstetric deserts
What Physicians Need to Know
Delivery Date AI is an adjunctive tool, particularly valuable for pregnancies where traditional dating methods are unreliable (e.g., irregular cycles, late prenatal care, absent first-trimester ultrasound). Use the Predicted Delivery Date (PDD) to complement your clinical judgment and standard-of-care assessments. If the PDD significantly differs (e.g., more than 10 days) from your estimated delivery date, a holistic reassessment of the clinical scenario and patient history is recommended. Remember that while the tool shows high accuracy in predicting days to delivery, its clinical impact on obstetric decision-making and outcomes in prospective trials is still being demonstrated.
The cloud-based Delivery Date AI is designed for easy integration into existing OB/MFM workflows. It is compatible with most standard ultrasound machines and accepts DICOM image uploads. Results are delivered rapidly (under 30 seconds) in real-time. The platform operates with HIPAA-compliant security and supports two-factor authentication for enhanced account security.
Details
| Category | OB/GYN AI, Radiology & Imaging AI |
| Pricing | Contact for pricing |
| Deployment | Cloud-based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated Delivery Date AI™ has received FDA De Novo authorization, establishing it as a new Class II device type with special controls. This clearance provides reasonable assurance of safety and effectiveness for its intended use in predicting delivery dates from ultrasound images. |
| Integrations | |
| EHR | Not specified |
| Specialties | Maternal-Fetal Medicine, Obstetrics & Gynecology, Radiology |
What the Web Says
Delivery Date AI by Ultrasound AI is an FDA De Novo-granted, cloud-based Software as a Medical Device (SaMD) designed to assist healthcare providers in predicting the delivery date of a pregnancy using standard ultrasound imaging. It is intended as an adjunctive tool for singleton pregnancies between 14 0/7 and 36 6/7 weeks gestation where traditional dating methods, such as last menstrual period or standard ultrasound gestational age dating, are unreliable. The technology analyzes the entire ultrasound image, including fetal and maternal characteristics, using deep-learning neural networks to provide a Predicted Delivery Date (PDD) in under 30 seconds.
Overall: PositiveStrengths
- Provides a Predicted Delivery Date (PDD) in under 30 seconds.
- Demonstrated statistically significant superiority over the standard-of-care Hadlock method in clinical studies for suboptimally dated pregnancies.
- Clinically validated through rigorous independent studies across multiple countries.
- Compatible with most standard ultrasound machines and integrates seamlessly into existing workflows.
- Aids in clinical judgment, particularly in cases of unreliable traditional dating methods or late presentation.
- Continuously learning and improving with additional data and retraining.
Limitations
- Intended as an adjunctive tool, not a replacement for physician judgment.
- Federal law restricts sale to or order by a physician or other licensed healthcare professional.
- Performance is validated for singleton pregnancies between 14 0/7 and 36 6/7 weeks gestation; use outside these parameters is off-label.
- No specific reviews from G2 or Capterra were found.
- Reddit discussions about AI in ultrasound generally express skepticism about AI replacing radiologists or creating hyperrealistic fetal images, rather than directly reviewing Delivery Date AI.
Based on reviews from: Ultrasound AI (ultrasound.ai), Clinician FAQ | Delivery Date AI - Ultrasound AI, Study Shows Using AI and Ultrasound Images Can Help Predict Delivery Timing, Delivery Date AI for Practices - Ultrasound AI, How does the FDA-cleared Delivery Date AI technology work? Raquel Dardik, MD, explains, Ultrasound AI receives FDA De Novo clearance for delivery date AI technology - EurekAlert!, Ultrasound AI Receives FDA De Novo Clearance for AI-Powered Delivery Date Prediction, FDA clears AI tool to predict delivery date - Becker's Hospital Review, AI-Powered Delivery Date Analysis Technology Receives FDA De Novo Clearance, Ultrasound AI receives De Novo clearance for predictive delivery date technology, FDA clears cloud-based AI system to forecast predicted delivery date - News-Medical, Can ultrasound + AI predict premature births? - YouTube, Delivery Date AI | FDA De Novo Granted Delivery Date Prediction, Meet the Team Behind Delivery Date AI - About Ultrasound AI, Ultrasound AI nets U.S. FDA clearance for delivery date prediction AI | AuntMinnie, 60 second full-body AI ultrasound to rival MRI, any radiologists want to weigh in on how outrageous this is? - Reddit, Very detailed ultrasound photo. But text looks garbled on the right. Seen on X. - Reddit, Has anyone used AI to make photo realistic images from 3D renders of fetal faces? : r/Ultrasound - Reddit, Is the photo used for this pregnancy announcement AI? I know the writing on the sign is artificial, but wondering about the rest. The ultrasound appears incorrect for a due date in October, the placement of the pine cones and (3?) baby shoes is odd, and the mountains seem under-defined : r/isthisAI - Reddit, Best AI Medical Diagnostic Platforms: User Reviews from July 2026 - G2
Last updated: 2026-07-22
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