Ultrasound AI develops AI software for prenatal ultrasound. Our product, Delivery Date AI™, received FDA De Novo marketing authorization (DEN250007) and analyzes standard ultrasound images to provide healthcare practitioners with a Predicted Delivery Date (PDD) for women who lack a reliable estimated delivery date — without adding steps to existing clinical workflows.

Delivery Date AI™ is a cloud-based Software as a Medical Device (SaMD) that analyzes standard obstetric ultrasound images to provide a Predicted Delivery Date (PDD). It is indicated for singleton pregnancies in women 18 years of age and older, from 14 0/7 through 36 6/7 weeks gestation, who lack a reliable estimated delivery date. It is not intended to predict or assess the risk of preterm birth. Results are delivered through a secure, cloud-based workflow.

Delivery Date AI™ may be used on eligible ultrasound studies between 14 0/7 and 36 6/7 weeks gestation, consistent with its FDA-granted indications for use.

DICOM images from an eligible ultrasound study are securely uploaded and analyzed by proprietary machine learning models. Clinicians receive a Predicted Delivery Date (PDD) to use as an aid to clinical judgment, alongside standard-of-care methods — without new hardware, additional scans, or extra patient visits.

Ultrasound AI’s models are trained and evaluated using large, diverse clinical datasets and retrospective research studies. Ongoing clinical collaborations continue to expand evidence generation and real-world validation.

Ultrasound AI is intended to support clinical decision-making by providing additional information. It does not make diagnoses or treatment decisions and should be used alongside clinical judgment and standard care guidelines.

Delivery Date AI™ received FDA De Novo marketing authorization (DEN250007) in February 2026 for use in the United States. In Brazil it is approved by ANVISA (registration 82499100004). In Chile it is offered under local regulatory allowances. Availability and indications vary by region.

The platform is designed to work with standard ultrasound workflows and integrate with PACS and clinical systems through secure, HIPAA-compliant software interfaces.

All data is handled using HIPAA-compliant security practices, including encrypted transmission, secure cloud processing, and appropriate data governance controls.

Ultrasound AI supports OB/GYN practices, maternal-fetal medicine groups, imaging centers, and health systems seeking earlier and more consistent prenatal insights.

Ultrasound AI extracts additional value from standard ultrasound images that clinicians already capture — providing an image-based Predicted Delivery Date where reliable dating is otherwise unavailable, with minimal workflow disruption and continuous model improvement using diverse clinical data.