R2 Technology Inc. has been granted U.S. Food and Drug Administration approval to market two software packages for use with the ImageChecker CT system during review of multi-detector CT (MDCT) chest exams. R2 made the announcement at the Stanford's University 6th Annual International Symposium on Multidetector-Row CT, June 23 - 26, in San Francisco.
One FDA clearance covers the Temporal Comparison software module, providing the ability to automatically track lung nodule progression or regression over time. The second clearance is for the Filling Defect Indicator software module, designed to help physicians visualize and evaluate filling defects in pulmonary arteries, such as pulmonary emboli.
R2 says that both applications are designed to address the information overload issue with MDCT and the potential of this overload to decrease diagnostic accuracy in an information intensive environment.