Product Launchdeep learningmedical imagingobstetricsultrasound ai
Ultrasound AI Gains FDA Clearance For Delivery-Date Tool
9.3
Ultrasound AI announced today that it received FDA De Novo clearance for Delivery Date AI, a cloud-based SaMD that predicts a Predicted Delivery Date (PDD) from standard ultrasound images in real time. Trained on millions of de-identified images and evaluated in a peer-reviewed PAIR study of more than 5,700 patients (R² = 0.92), the tool integrates with existing OB/MFM workflows and is now available across the United States.
Key Points
- 1Announces FDA De Novo clearance for Delivery Date AI, a cloud SaMD predicting PDD from ultrasound
- 2Demonstrates high accuracy: peer-reviewed PAIR study (5,700+ patients) reported R² of 0.92 predicting days
- 3Enables clinicians to individualize prenatal planning and potentially reduce preterm birth-related costs and interventions
Scoring Rationale
Regulatory approval plus strong peer-reviewed validation drive high impact, limited by focus on a single clinical vertical.
Sources
Public references used for this report.
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