Chinese Regulatory Approval Secured for Digital Mammography CAD Technology

The SecondLook Digital mammography computer-aided detection (CAD) system has gained approval by the State Food and Drug Administration (SFDA) in the People's Republic of China.

The approval allows iCAD's SecondLook Digital CAD technology to be sold with GE Healthcare (Chalfont St. Giles, UK) digital mammography systems in order to assist radiologists in distinguishing potential cancers from other anomalies on a mammogram. iCAD (Nashua, NH, USA) is an industry-leading provider of advanced image analysis, workflow solutions, and radiation therapies for the early identification and treatment of cancer,

"Across the globe, film-based mammography systems are being upgraded to the new standard-of-care, full-field digital mammography. Computer-aided detection is an important tool used in conjunction with digital mammography that highlights areas warranting closer evaluation," said Ken Ferry, president and CEO of iCAD. "We are honored to now have regulatory approval to provide women in China with access to iCAD's SecondLook technology and we look forward to working with GE Healthcare as our partner in the country."

ICAD's SecondLook Digital utilizes sophisticated pattern recognition technology and is very proficient in helping the radiologist identify subtle tumors, or those that are most likely to be missed. Using an advanced 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.

"We congratulate iCAD on securing regulatory approval for its SecondLook Digital CAD solution in the People's Republic of China. GE Healthcare continues to make significant progress in providing solutions for breast cancer detection and diagnosis globally, and we are excited to now offer women in China the benefit of SecondLook Digital CAD as part of our mammography solution. These tools can potentially help healthcare professionals diagnose breast cancer at an earlier stage, which ultimately benefits the patient," said David Caumartin, GE Healthcare's general manager mammography.

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 February 2009 issue of the American Journal of Roentgenology. The study found that CAD with full-field digital mammography revealed a high sensitivity in identifying cancers, it correctly marked 94% of biopsy-proven tumors, and the sensitivity of iCAD's SecondLook CAD was not dependent on the size of the tumor, as it was equally accurate with small and large lesions.

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