Get answers to common questions about our AI-powered prenatal technology
From technical specifications to clinical applications, find comprehensive information about how Ultrasound AI is transforming prenatal care with cutting-edge artificial intelligence.
What does Ultrasound AI do?
Ultrasound AI offers a science-backed AI platform that predicts your baby's likely delivery date with greater accuracy than the traditional 40-week estimate. Using standard ultrasound images, our technology can deliver insights as early as 6 weeks into pregnancy, empowering healthcare providers and expectant parents with actionable information to improve outcomes and reduce the burden of preterm birth, a leading cause of infant mortality globally.
How accurate is the technology?
Ultrasound AI predicted due dates for full-term pregnancies with high accuracy. It also correctly identified most early deliveries, while keeping false alarms low. This was validated by the University of Kentucky's PAIR study (5,714 patients, 19,940 exams).
Where is Ultrasound AI available?
We have full approval in Brazil (ANVISA) and Chile. FDA De Novo clearance is expected in Q3 2025 for the United States. We're actively expanding to other markets globally.
When was Ultrasound AI founded, and where is it based?
Founded in 2019, Ultrasound AI is headquartered in Colorado, with a distributed team supporting remote operations. This structure optimizes talent acquisition and operational flexibility as we scale.
What problem are we solving?
Preterm birth affects 1 in 10 babies worldwide, costing the U.S. alone $30 billion annually and remaining the top cause of death for children under 5. Current tools fail to predict delivery dates accurately or identify preterm risks early enough for effective intervention. Ultrasound AI addresses this gap with a scalable, image-based solution that outperforms traditional methods, offering a pathway to reduce both human and economic costs.
Is it safe?
Yes. It uses the same safe ultrasound you already receive—no new procedures, just smarter analysis.
What sets Ultrasound AI apart?
Our approach combines cutting-edge AI—trained on over 8 million ultrasound images— with a focus on early, precise predictions (predicted dates for full-term pregnancies matched actual delivery dates very closely). Unlike competitors relying on lab tests or manual measurements, our technology integrates seamlessly into existing ultrasound workflows, delivering results in seconds. This efficiency, paired with our roadmap for broader prenatal diagnostics, positions us as a transformative force in maternal-fetal medicine.
What is Delivery Date AI™?
Delivery Date AI™ is our flagship platform, leveraging deep learning (convolutional neural networks and transformers) to analyze ultrasound images and predict delivery dates with high precision. It identifies subtle patterns invisible to the human eye, offering insights from as early as 6 weeks gestation.
Can it predict preterm births and beyond?
Yes it excels at preterm prediction. Please see our latest publications for results.
How does it integrate with existing systems?
Delivery Date AI™ works with most cart-based ultrasound machines from the past 20 years, requiring no new hardware. It connects to PACS systems or uploads images directly, delivering results in seconds via a cloud-based platform—streamlining adoption without disrupting clinical workflows.
How do we protect patient data?
We prioritize security with HIPAA-compliant servers, industry-standard encryption, and rigorous de-identification processes. Our commitment to privacy ensures trust from providers and patients alike, validated by third-party monitoring in our research studies.
What outcomes do we deliver?
Patients: Early warning if your baby might arrive sooner than expected improves care and preparation.
Providers: Supports better decision-making and standardized assessments.
Systems: May help reduce NICU stays and optimize resources through better planning—potentially saving billions annually.
Where do we stand on approvals?
We've achieved full approval in Brazil (ANVISA) and Chile (exempt), with FDA De Novo pending—a pivotal milestone for U.S. commercialization. This multi-jurisdictional strategy mitigates risk and accelerates global reach.
What's our IP position?
Five U.S. patents are granted, with three pending, plus approvals in Israel and Singapore. Our IP protects core algorithms and methodologies, while our dataset provides a defensible moat against competitors.
How do we ensure compliance?
HIPAA-compliant data handling, continuous audits, and a regulatory team ensure we meet stringent standards. Our ethical AI development aligns with clinical trial guidelines (e.g., SPIRIT-AI), preparing us for post-market surveillance requirements.
Who are we working with?
University of Kentucky: Validated our tech in the PAIR study; more trials planned. OEMs: Integrating with ultrasound manufacturers. Pharma: Exploring therapeutic applications. Distributors: Expanding global reach.
What's the collaboration outlook?
Multicenter U.S. trials and international studies will further validate and refine our platform, while strategic partnerships position us as a standard in prenatal care.
What's the long-term vision?
We aim to lead AI-driven prenatal diagnostics, integrating into standard ultrasound workflows worldwide and expanding into a full suite of maternal-fetal solutions. Success means better outcomes for millions of pregnancies and a transformed healthcare landscape.
What's the clinical impact?
Early warning if your baby might arrive sooner than expected enables timely interventions, potentially reducing preterm birth complications and costs—translating science into real-world value.