News | May 17, 2011

iCad Secures Chinese Regulatory Approval for Digital Mammography CAD Technology

May 17, 2011 – iCAD, an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, announces that it has secured regulatory approval for its SecondLook Digital by the State Food and Drug Administration (SFDA) in the People’s Republic of China. The approval allows iCAD’s SecondLook Digital computer-aided detection (CAD) technology to be sold with GE digital mammography systems in order to assist radiologists in distinguishing potential cancers from other anomalies on a mammogram.
iCAD’s SecondLook Digital utilizes advanced pattern recognition technology and is extremely proficient in helping the radiologist detect subtle cancers, or those that are most likely to be missed. Using a sophisticated algorithm, the CAD software identifies and marks suspicious areas on a mammogram for the radiologist to review. As part of its regulatory approval in China, the product went through testing by the SFDA.

CAD technology has been included in several peer-reviewed studies, including an article titled “Detection of Breast Cancer with Full-Field Digital Mammography and Computer-Aided Detection,” in the American Journal of Roentgenology (Volume 192, Issue 2). The study found the following:
•    CAD with full-field digital mammography showed a high sensitivity in identifying cancers.
•    The SecondLook CAD correctly marked 94 percent of biopsy-proven cancers.
•    The sensitivity of iCAD’s SecondLook CAD was not dependent on the size of the tumor; it was equally accurate with small and large lesions.

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