Breast tomosynthesis is a new method for breast cancer screening and diagnosis. Unlike prior-gen- eration mammography systems, which generate 2-dimensional images, breast tomosynthesis produces 3-dimensional images that are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density.

In clinical studies Hologic submitted to the FDA, radi- ologists reading 2-dimensional + 3-dimensional mam- mography (breast tomosynthesis) compared to 2-dimensional mammography alone demonstrated supe- rior clinical performance in specificity, the confidence to rule out breast cancer without recalling the patient for fur- ther study, and also demonstrated improved sensitivity, the proportion of mammograms which include breast cancers that were correctly diagnosed. Based on pooled multi-reader receiver operating characteristic (ROC) anal- ysis, Hologic’s clinical trials reviewed by the FDA showed the potential to increase cancer detection by up to 16% and the potential to reduce recall rate by up to 40% when using combo-mode (2-dimensional + 3-dimen- sional breast tomosynthesis) compared with 2-dimen- sional mammography alone.