Lung-CAD
Imagen Technologies, IncLung-CAD is an AI-powered software that helps physicians by analyzing chest X-rays to identify areas showing interstitial thickening. It highlights these areas with bounding boxes, serving as a concurrent reading aid to improve detection. It does not replace physicians but supports them in interpreting lung images more effectively in adults.
Intended Use
Lung-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for interstitial thickening. It uses a deep learning algorithm to identify regions of interest with interstitial thickening and produces boxes around the ROIs. Intended for use as a concurrent reading aid for physicians interpreting chest X-rays, not for diagnosis. Indicated for adults only.
Technology
Lung-CAD uses supervised deep learning and computer vision techniques to analyze digital chest X-rays. It generates DICOM Presentation State files with bounding boxes labeled as interstitial thickening to highlight detected regions. Output overlays can be toggled on and off within PACS viewers and the processing is cloud-based with HIPAA compliance.
Performance
Standalone testing on 5,000 chest X-ray cases demonstrated high sensitivity (91.3%), specificity (86.6%), and AUC (0.961) in detecting interstitial thickening. A retrospective multiple reader, multiple case clinical study showed significant improvement in reader accuracy with Lung-CAD aid versus unaided reads, with an AUC improvement of 0.0797 (p<0.001).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/20/2022
8 months - 2
FDA Approval
9/13/2023
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