The FDA's Radiological Devices Panel of the Medical Devices Advisory Committee unanimously recommended approval of R2 Technology Inc.'s ImageChecker CT computer-aided detection (CAD) system for the detection of lung nodules during review of multi-detector CT (MDCT) chest exams with conditions.
The panel's positive recommendation now proceeds to the FDA for final clearance. If approved, R2's ImageChecker CT CAD system would be the first CAD system for the detection of lung nodules on CT exams available in the United States.
R2 introduced the ImageChecker CT CAD system with OmniCAD technology in Europe in March 2003. The CAD algorithms are designed to automatically detect potential areas of interest to increase physician accuracy by decreasing observational oversights, as well as provide workflow-enhancing tools, including automatic measurement and characterization information of the detected lung nodules.
R2 Technology's proprietary CAD technology provides detection of nodules in chest CT exams taken for any clinical indication, not just for lung cancer screening studies.
R2 already has FDA 510(k) clearance for its workflow-enhancing tools of the ImageChecker CT LN-500 system. In January, R2 received 510(k) clearance for temporal comparison tools on the ImageChecker CT workstation to track nodule growth progression or regression over time.