Aorta-CAD
Imagen Technologies, IncAorta-CAD is an AI-powered software tool designed to assist physicians in analyzing chest X-rays. It detects and highlights areas that may show aortic calcification or dilation, which can indicate chronic aortic conditions. This helps radiologists by drawing attention to suspicious regions, improving diagnostic accuracy without replacing physician judgment.
Intended Use
Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). It uses a deep learning algorithm to identify and produce boxes around ROIs labeled as Aortic calcification or Dilated aorta. Intended for use as a concurrent reading aid for physicians to detect findings suggestive of Aortic Atherosclerosis or Aortic Ectasia, indicated for adults only.
Technology
The device is a software-only tool that uses supervised deep learning and computer vision techniques on digital chest X-ray images. It produces output overlays with bounding boxes around detected regions labeled as either Aortic calcification or Dilated aorta, integrated into the physician’s PACS viewer for concurrent reading aid.
Performance
Performance testing on 5,000 chest radiograph cases showed high sensitivity (0.91), specificity (0.896), and AUC (0.974). Clinical reader studies demonstrated significant improvement in detection accuracy when aided by Aorta-CAD, proving safety and effectiveness as an adjunct reading aid.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/8/2021
11 months - 2
FDA Approval
9/20/2022
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