Products

Delivery Date AI
Ultrasound AI
OB/GYN AI
Delivery Date AI™ is an FDA De Novo cleared cloud-based AI technology that determines a Predicted Delivery Date (PDD) solely from standard ultrasound images to aid clinical decision-making for singleton pregnancies between 14 0/7 and 36 6/7 weeks gestation where a reliable estimated delivery date is unavailable.

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About Ultrasound AI

Ultrasound AI is a healthcare artificial intelligence company dedicated to transforming prenatal care through its innovative, image-only AI solutions. Their flagship product, Delivery Date AI™, is an FDA De Novo-granted cloud-based Software as a Medical Device (SaMD) designed to assist healthcare providers in accurately predicting delivery dates as early as eight weeks into pregnancy. This technology leverages an ensemble of deep-learning neural networks, trained on millions of diverse ultrasound images, to analyze fetal and maternal characteristics, providing clinicians with earlier and more precise insights into a pregnancy’s progression.

The company’s platform aims to reduce clinical uncertainty, particularly in suboptimally dated pregnancies or those with late-entry prenatal care, thereby enabling more informed clinical decision-making and potentially improving maternal and fetal outcomes by identifying and addressing potential risks of preterm birth. Delivery Date AI™ is designed for seamless integration into existing ultrasound workflows, making it scalable across high-volume health systems, resource-constrained clinics, and obstetric deserts. Beyond delivery date prediction, Ultrasound AI’s patented technology is expanding to determine clinical values across a range of conditions, further augmenting clinicians with actionable insights derived from standard ultrasound.

Focus Areas

prenatal care delivery date prediction preterm birth risk maternal-fetal medicine obstetrics AI-powered ultrasound analysis

Business Intelligence

Key InvestorsIgnite Healthcare Network
PartnershipsUniversity of Kentucky (PAIR study), market entry in Brazil and Chile
Technologycloud-based Software as a Medical Device (SaMD), deep-learning neural networks, image-only AI, patented technology
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Prenatal Care & Maternal-Fetal Medicine
Ultrasound AI specializes in enhancing prenatal care by providing AI-powered insights from standard ultrasound images. Their technology supports early identification of potential risks and aids in personalized care planning, particularly in maternal-fetal medicine.
Delivery Date Prediction
The company offers a flagship 'Delivery Date AI' technology that accurately predicts delivery dates solely from standard ultrasound images. This cloud-based Software as a Medical Device (SaMD) has received FDA De Novo clearance and is designed to assist clinicians, especially when traditional dating methods are unreliable.
Preterm Birth Risk Assessment
Ultrasound AI's technology significantly improves the prediction performance for spontaneous preterm birth (PTB) by analyzing ultrasound images. The AI model continuously learns and improves its accuracy, offering a non-invasive and scalable tool to address the challenge of PTB prediction.
AI-Powered Ultrasound Analysis
Their core specialization lies in leveraging deep-learning neural networks to analyze millions of de-identified ultrasound images. This AI-driven analysis extracts critical information, including fetal and maternal characteristics, to provide precise and objective insights, augmenting human interpretation.
Obstetrics Workflow Enhancement
The technology is designed to integrate seamlessly into existing obstetrics and maternal-fetal medicine (MFM) workflows, providing real-time decision support without requiring new hardware or disrupting current practices. It automates tasks like measurements and data analysis, increasing efficiency.
Physician Tip

For physicians, Ultrasound AI's 'Delivery Date AI' offers a powerful adjunctive tool to enhance clinical decision-making, particularly in pregnancies with unreliable traditional dating. Its ability to provide accurate, image-based predicted delivery dates and improve preterm birth risk assessment can lead to earlier, more informed interventions and personalized care plans. The system's independence from clinical measurements and maternal history, coupled with its continuous learning capability, provides robust and generalizable insights. By streamlining workflows and reducing the burden of manual tasks, it frees up valuable time for clinicians to focus on patient interaction and complex cases, ultimately improving diagnostic confidence and patient outcomes, especially in high-resource and resource-limited settings.

Ultrasound AI's technology is a cloud-based Software as a Medical Device (SaMD) designed for seamless integration. It is compatible with most existing ultrasound machines, allowing images to be uploaded to the cloud and results delivered within seconds. The system integrates into current OB/MFM prenatal visit workflows without requiring new hardware or significant workflow disruption, making it scalable across various healthcare settings.

Products by Ultrasound AI

1 product in the directory

Delivery Date AI
Ultrasound AI
OB/GYN AI
Delivery Date AI™ is an FDA De Novo cleared cloud-based AI technology that determines a Predicted Delivery Date (PDD) solely from standard ultrasound images to aid clinical decision-making for singleton pregnancies between 14 0/7 and 36 6/7 weeks gestation where a reliable estimated delivery date is unavailable.

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Frequently Asked Questions

Ultrasound AI's Delivery Date AI is a cloud-based Software as a Medical Device (SaMD) that seamlessly integrates into existing OB/MFM prenatal visit workflows, providing a Predicted Delivery Date (PDD) in real-time from standard ultrasound images. This technology aims to provide clinicians with unprecedented insight into pregnancy progression, aiding in more informed decision-making and potentially reducing the likelihood of complications associated with inaccurate dating. While it improves delivery timing prediction, its direct assessment of preterm birth risk is noted as having limited sensitivity by the FDA.
Ultrasound AI's Delivery Date AI has demonstrated high accuracy, achieving an Ru00b2 value of 0.92 for predicting the day of delivery using only standard ultrasound images. This was validated in a peer-reviewed PAIR (Perinatal Artificial Intelligence in Ultrasound) Study, published in The Journal of Maternal-Fetal & Neonatal Medicine, which involved training on millions of de-identified ultrasound images and included over 5,700 patients. The AI's performance for spontaneous preterm birth prediction also improved with iterative retraining.
Ultrasound AI's Delivery Date AI has received FDA De Novo clearance, signifying its regulatory approval as a novel Software as a Medical Device. The company ensures data privacy by operating through a HIPAA-compliant portal where clinicians upload de-identified standard ultrasound images. This adherence to HIPAA standards protects electronic Protected Health Information (ePHI) through measures like encryption and access controls.
Delivery Date AI is designed for seamless integration with most existing ultrasound systems and current OB/MFM prenatal visit workflows. Installation can take just minutes, and the cloud-based software delivers results in seconds after image upload, minimizing workflow disruption. While direct EMR/PACS integration specifics for this product are not detailed, AI solutions in medical imaging generally integrate via APIs or enterprise platforms to streamline workflows and provide comprehensive data views.
While specific pricing details for Ultrasound AI's Delivery Date AI are not publicly disclosed, AI solutions in healthcare often utilize subscription or usage-based models. Ultrasound AI indicates that its technology offers organizations scalability and the potential to reduce long-term costs by improving maternal outcomes, particularly by addressing issues related to preterm birth. The improved accuracy in delivery date prediction can lead to more efficient resource allocation and better patient management.
Although specific details on Ultrasound AI's support and training programs are not explicitly mentioned, the company emphasizes minimal onboarding and no workflow disruption for its Delivery Date AI. Generally, medical AI companies provide comprehensive training and technical support to ensure effective integration and utilization of their devices, often including guidance on regulatory compliance and clinical performance.
Ultrasound AI is a pioneer in artificial intelligence applications for medical imaging, with its flagship Delivery Date AI having received FDA De Novo clearance. The company has demonstrated a commitment to clinical validation through its collaboration with the University of Kentucky on the peer-reviewed PAIR Study. With key leadership including Robert Bunn (President & Founder) and Dr. Raquel Dardik (Chief Medical Officer), Ultrasound AI is positioned for ongoing development in maternal-fetal medicine.

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