Computer-aided detection (CAD) devices are of increasing interest to practicing radiologists. Many radiologists are familiar with CAD for detecting microcalcifications and masses on mammograms. The earliest US Food and Drug Administration (FDA) approvals for mammographic CAD devices were in 1998 . Since then, more than a dozen CAD systems have been approved for detecting abnormalities such as lung nodules on chest radiography and computed tomography, colon polyps on computed tomographic colonography, and pulmonary emboli on chest computed tomography .
Cross-sectional imaging studies are being performed with increasing frequency, and the number of images per examination is growing exponentially . Hence, there is a steadily building need for computerized devices to help radiologists interpret this avalanche of images in an accurate and timely fashion.
Despite the great potential for CAD devices to make a positive impact in radiology, new CAD technologies are arriving slowly to the reading room. For example, researchers have developed CAD systems that detect or classify lesions in the solid abdominal organs; detect bone lesions and fractures; make fully automated assessments of bone mineral density, visceral fat, and bone age; and detect neurologic and vascular abnormalities such as cerebral aneurysms . Yet none of these systems is available as a commercial product in the United States.
Why does it take so long for these new technologies to make their way from the bench to the viewing console? Delays and impediments occur at each stage of the CAD development and implementation lifecycle: the great expense in collecting and annotating cases needed to train the CAD systems, the lack of standards to enable CAD systems to be plugged into picture archiving and communication systems (PACS), the lack of reimbursement for the cost of the software and the time spent using it , and the complexity and difficulty of getting FDA approval.
Gallas et al address these issues in their paper in this month’s Academic Radiology . They report on the Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices, held July 14, 2010, in Rockville, Maryland . Clinicians and leaders from academia, industry, the FDA and the National Institutes of Health, and other government agencies attended the workshop. The primary goal was to improve the quality of CAD and computer-aided diagnosis device evaluations submitted to the FDA for approval and clearance.
There is a substantial body of knowledge regarding experimental and statistical methods appropriate for evaluating CAD devices. Gallas et al provide the background of this body of knowledge, focusing on studies and analyses that have been used successfully in bringing CAD devices to approval.
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Acknowledgment
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