Ultrasound AI

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Ultrasound AI is a Clinical & Healthcare Pro tool that uses AI to predict delivery dates from ultrasound images. It is FDA De Novo granted and helps clinicians with suboptimally dated pregnancies.

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At a glance

Pricing

Likely Not Free

Free tier

API

Skill level

Technical

About

What is Ultrasound AI?

Ultrasound AI's Delivery Date AI™ is an FDA De Novo granted, cloud-based Software as a Medical Device (SaMD) designed to assist healthcare providers in predicting delivery dates for singleton pregnancies between 14 0/7 and 36 6/7 weeks gestation where a reliable estimated delivery date is unavailable. It provides an independent, image-based Predicted Delivery Date (PDD) to support clinical judgment, improving prediction accuracy by 58% compared to standard methods. The tool is compatible with GE and Philips ultrasound systems and processes DICOM files containing 2D grayscale static images. It is not intended to replace clinical expertise or predict preterm birth, but rather to aid in clinical decision-making.

Best used for

Ideal for OB/GYNs and MFM specialists who need to accurately predict delivery dates for suboptimally dated singleton pregnancies, and to support clinical judgment. Especially valuable for improving maternal care outcomes and providing confidence to expectant families.

Common actions

predict delivery dates

analyze ultrasound images

aid clinical decision-making

improve pregnancy dating

Capabilities

Key features

AI delivery date prediction
FDA De Novo granted
Cloud-based SaMD
58% prediction error reduction
HIPAA compliant
DICOM file processing
Supports GE/Philips ultrasound

Target Audience

doctornurse

Integrations

Not yet documented

Pricing & Plans

Likely Not Free

Not publicly disclosed. Check ultrasound.ai for current pricing.

FAQs

What types of pregnancies is Delivery Date AI indicated for?

Delivery Date AI is indicated for singleton pregnancies in women 18 years and older, from 14 0/7 weeks through 36 6/7 weeks gestation, who lack a reliable estimated delivery date. It is not for multiple gestations or pregnancies with known fetal anomalies.

Which ultrasound systems and image formats are compatible with Delivery Date AI?

Delivery Date AI has been validated for use with 2D grayscale (including Doppler) images from GE and Philips ultrasound systems, using convex, micro-convex, and transvaginal probes. It accepts DICOM files (.dcm) but does not support JPEG, PNG, 3D/4D, M-mode, cine loops, or video formats.

How should the Predicted Delivery Date (PDD) be used by clinicians?

The PDD should be used as an aid to clinical judgment, alongside standard-of-care methods for assessing gestational age. It is not intended to replace clinical expertise or serve as the sole basis for decisions. If the PDD differs from the clinician's EDD by more than 10 days, a holistic reassessment is recommended.

What is the regulatory status of Delivery Date AI?

Delivery Date AI has received FDA De Novo designation in the United States, establishing a new regulatory category for AI-powered delivery date prediction. It is also approved in Brazil (ANVISA) and offered in Chile under local regulatory allowances.

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