R2 gets FDA nod for CAD for multislice CT lung nodule detection

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CAD developer R2 Technology Inc. this week announced it received U.S. Food and Drug Administration (FDA) approval for its ImageChecker CT CAD software system.

R2 said the ImageChecker CT system is the first CAD system to receive an approval for computer-aided detection of solid lung nodules during review of multi-detector CT (MDCT) chest exams. Early lung cancer often presents as nodules and can be difficult to detect in its early stages.

CAD is used after the radiologist first conducts a standard review. The CAD algorithms examine the CT study in three dimensions and automatically detect potential areas of interest, increasing physician accuracy by decreasing observational oversights.

Last month, R2 announced FDA clearance to market two software packages for use with the ImageChecker CT system: temporal comparison software module, which provides automatic three-dimensional registration and the ability to automatically track lung nodule progression or regression over time; and the filling defect indicator software module, designed to help physicians visualize and evaluate filling defects in pulmonary arteries, such as pulmonary emboli.