US Pharm. 2011;36(3)(Oncology suppl):9.
The FDA approved the Selenia Dimensions System (Holigic, Inc.), the first x-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis. Approximately 10% of women undergo additional testing after the initial conventional two-dimensional (2-D) screening examination for abnormalities that are later determined to be noncancerous.The Selenia Dimensions System can provide both 2-D and 3-D x-ray images of the breasts, and the 3-D images may help physicians more accurately detect and diagnose breast cancer. During the approval process, the FDA reviewed results from two studies where board-certified radiologists reviewed 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7% improvement in their ability to distinguish between cancerous and noncancerous cases over viewing 2-D images alone.
