About
Ultrasound AI develops clinically informed AI software for obstetric care, with its flagship product Delivery Date AI™ receiving FDA De Novo authorization — the first AI-enabled post-processing software of its kind for delivery date prediction. The tool analyzes routine pregnancy ultrasound images to produce a Predicted Delivery Date (PDD) intended to aid clinicians when a standard estimated delivery date (EDD) is unavailable or unreliable. Delivery Date AI™ is indicated for singleton pregnancies in women 18 years and older, from 14 0/7 through 36 6/7 weeks gestation. It is designed to complement, not replace, clinical judgment and standard-of-care methods. The software is not intended to predict or assess the risk of preterm birth. The tool addresses a critical gap in maternal care: inaccurate pregnancy dating contributes to preterm birth complications, which account for significant annual healthcare costs and global deaths. By offering image-based AI insights, Ultrasound AI helps clinicians make more confident, precise delivery timing estimates. Currently available via a Provider Portal in North America and South America (including Brazil and Chile), the platform is trusted by OB/GYNs and MFM specialists seeking to improve outcomes for expectant families. Ultrasound AI is actively expanding its U.S. commercial deployment and healthcare partnerships.
Key Features
- FDA De Novo Authorization: Delivery Date AI™ has received FDA De Novo authorization, establishing it as a Class II medical device with special controls ensuring safety and effectiveness.
- AI-Powered Ultrasound Analysis: Analyzes routine obstetric ultrasound images to generate a Predicted Delivery Date (PDD) for pregnancies lacking a reliable EDD.
- Wide Gestational Range Support: Indicated for use in singleton pregnancies between 14 0/7 and 36 6/7 weeks gestation, covering a broad window of clinical need.
- Multi-Country Regulatory Approval: Approved in the U.S. (FDA), Brazil (ANVISA), and available under local regulatory allowances in Chile, enabling broad regional deployment.
- Clinical Decision Support: Provides image-based delivery date insights to aid, not replace, clinician judgment alongside standard-of-care gestational assessment methods.
Use Cases
- Providing a Predicted Delivery Date for pregnant women who lack a reliable estimated delivery date due to irregular cycles or late prenatal care entry.
- Supporting OB/GYNs and MFM specialists in making more confident delivery timing decisions during routine obstetric ultrasound appointments.
- Helping maternal care clinics in the U.S., Brazil, and Chile improve pregnancy dating accuracy and reduce risks associated with inaccurate due dates.
- Augmenting standard-of-care gestational age assessment with AI-based image analysis for singleton pregnancies in the second and early third trimesters.
- Enabling healthcare practices to offer patients additional confidence and transparency around their pregnancy timeline through regulated AI tools.
Pros
- Regulatory Credibility: FDA De Novo authorization and ANVISA approval provide strong regulatory backing, making it suitable for use in clinical settings with confidence.
- Addresses a Real Care Gap: Directly targets the problem of unreliable pregnancy dating, which has documented consequences for maternal and neonatal outcomes globally.
- Non-Invasive Integration: Works with routine obstetric ultrasound workflows, requiring no additional procedures or equipment beyond standard imaging.
Cons
- Narrow Indication Scope: Only indicated for singleton pregnancies without a reliable EDD, limiting its applicability to a specific subset of obstetric cases.
- Not for Preterm Risk Assessment: Explicitly not intended to predict or assess preterm birth risk, which may limit its utility for higher-risk obstetric management.
- Limited Geographic Availability: Currently available in only a few countries (U.S., Brazil, Chile), restricting access for global healthcare providers.
Frequently Asked Questions
What is Delivery Date AI™ and what does it do?
Delivery Date AI™ is an FDA De Novo authorized AI software that analyzes obstetric ultrasound images to generate a Predicted Delivery Date (PDD) for singleton pregnancies where a reliable estimated delivery date is unavailable.
Who is Delivery Date AI™ intended for?
It is intended for use by clinicians — including OB/GYNs and maternal-fetal medicine (MFM) specialists — in women 18 years and older carrying singleton pregnancies between 14 0/7 and 36 6/7 weeks gestation.
Does Delivery Date AI™ replace the clinician's judgment?
No. The output is designed to aid clinical decision-making and does not replace clinical judgment or standard-of-care methods for assessing gestational age.
In which countries is Delivery Date AI™ available?
It is FDA authorized for use in the United States, ANVISA approved in Brazil (registration number 82499100004), and available in Chile under local regulatory allowances.
Can Delivery Date AI™ predict preterm birth risk?
No. Delivery Date AI™ is not intended to predict or assess the risk of preterm birth. Its sole purpose is to aid in estimating the predicted delivery date.
