Lung-CAD
Imagen Technologies, IncLung-CAD is an AI-based software designed to assist physicians by analyzing chest X-ray images and identifying regions of lung hyperinflation. It highlights these regions with boxes on the X-ray images to support concurrent reading, improving detection accuracy without replacing clinical diagnosis.
Intended Use
Lung-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for lung hyperinflation. The device uses a deep learning algorithm to identify regions of interest (ROIs) with lung hyperinflation and produces boxes around the ROIs. Lung-CAD is intended for use as a concurrent reading aid for physicians interpreting chest X-rays. The device is not intended for clinical diagnosis of any disease. It does not replace the role of the physician or of other diagnostic testing in the standard of care for lung parenchymal findings. Lung-CAD is indicated for adults only.
Technology
Lung-CAD uses supervised deep learning and modern computer vision techniques to analyze digital chest X-ray images. It operates on a secure cloud-based platform and produces output overlays with labeled bounding boxes identifying regions of lung hyperinflation on chest radiographs, which can be toggled on/off within a PACS viewer. It is a software-only solution intended as a concurrent reading aid.
Performance
Performance testing includes software verification and validation following FDA guidance, standalone testing on 5,000 chest X-rays demonstrating high sensitivity (0.898), specificity (0.894), and AUC (0.964), and a clinical multiple reader, multiple case (MRMC) retrospective study showing statistically significant reader performance improvement with Lung-CAD assistance in detecting lung hyperinflation (p<0.001).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/11/2023
8 months - 2
FDA Approval
10/3/2023
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