FDA Approves Software System to Help Detect Lung Nodules

The Food and Drug Administration (FDA) has approved a new image analysis system designed to help radiologists review computed tomography (CT) images of the chest to aid in the detection of solid nodules in the lungs. Such nodules can be malignant.

The system uses computer aided detection (CAD) software to analyze CT images that the radiologist has previously reviewed, highlighting areas of the image that appear to be solid nodules. Because the device works independently of the radiologist, it can detect suspect areas that the radiologist may have missed.

The product, the first of its kind for use with CT chest exams, is the ImageChecker CT CAD software system, manufactured by R2 Technology, Inc., of Sunnyvale, Calif.

FDA approval of the system was based on a clinical study conducted by the manufacturer designed to measure whether or not use of the system enhanced radiologists? ability to detect nodules on chest CT images. In the study, 15 radiologists independently reviewed 90 cases from lung CT scans without the ImageChecker system, and then again using the new system. When radiologists used the new system, they were able to identify more nodules than they could without it, improving their ability to detect lung nodules that require further evaluation.

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