Computer-aided detection (CAD) technology firm R2 Technology Inc. is one step closer to FDA clearance for its ImageChecker CT lung CAD system.
The FDA sent R2 an approval recommendation from an agency advisory panel and an approvable letter for the detection of suspicious lung nodules using CT as an imaging modality.
R2's CT lung CAD algorithms are designed to automatically detect potential areas of interest in the review of chest CT exams and to improve accuracy in lung nodule detection.
Susan Wood, PhD, vice president of CT products for R2, said that when the company launched the commercial use of CAD for mammography, R2 "knew that the knowledge gained from this application would provide an excellent basis for applying CAD to other disease sites."
R2's ImageChecker CAD system with OmniCAD technology is used by hospitals and imaging centers as an aid to radiologists for the early detection of breast cancer.