Ultrasound AI's cloud-based Delivery Date AI receives FDA De Novo clearance for predicting delivery timing from standard ultrasound images.
Key Details
- 1FDA De Novo clearance granted for Delivery Date AI by Ultrasound AI.
- 2The AI predicts a Predicted Delivery Date (PDD) using only standard ultrasound images.
- 3The solution is cloud-based, integrates into OB/MFM prenatal workflows, and provides real-time results to clinicians.
- 4Trained on millions of de-identified ultrasound images and evaluated in a peer-reviewed study with over 5,700 patients.
- 5The study reported a predictive accuracy of 0.92 R² in forecasting days to delivery.
- 6The technology is compatible with most ultrasound machines and can be installed quickly with minimal workflow disruption.
Why It Matters
The FDA clearance of this AI tool marks significant progress in expanding the utility of imaging AI for obstetrics by improving delivery date predictions, particularly where traditional dating methods are insufficient. This innovation could enhance individualized care, potentially reducing preterm births and related healthcare costs, and has broad scalability across varied clinical settings.
Source
EurekAlert
Related News
•EurekAlert
Sandia Labs Deploys AI-Augmented Imaging for Ceramic Component Inspections
Sandia National Laboratories is introducing AI-assisted optical and acoustic imaging systems to streamline and improve ceramic component inspections for nuclear deterrence.
•EurekAlert
FDA Approves Johns Hopkins AI Tool for Early Sepsis Detection
FDA clears an AI-driven system developed by Johns Hopkins to detect sepsis up to 48 hours earlier and reduce mortality rates.
•EurekAlert
AI Software Matches Invasive Gold Standard in Coronary Flow Assessment
AI-based FFRangio software performs comparably to invasive pressure wire methods for evaluating coronary artery disease in a major international clinical trial.