Medical Technology

FDA clearances granted for software to review multi-detector CT chest exams

Published in Cancer Weekly, July 27th, 2004

R2 Technology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to market two software packages for use with the ImageChecker CT system during review of multi-detector CT (MDCT) chest exams.

One FDA clearance covers the Temporal Comparison software module, providing the ability to automatically track lung nodule progression or regression over time. Growth rate is one important indicator of clinical significance of the finding and automating this process has potential for significant time savings. The second clearance is for the Filling Defect Indicator software module, designed to help physicians visualize and evaluate filling...

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Source: Cancer Weekly (2004-07-27)

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