Tomosynthesis is a revolutionary technology that gives radiologists the ability to identify and characterize individual breast structures without the confusion of overlapping tissue. During a tomosynthesis scan, multiple, low-dose images of the breast are acquired at different angles. These images are then used to produce a series of one-millimeter thick slices that can be viewed as a three dimensional reconstruction of the breast.

Instead of viewing all tissue complexities superimposed as they are on a traditional 2D mammogram, the radiologist can now scroll through the layers of the breast in one-millimeter thick slices. Reviewing breast tissue slice by slice removes the confusion of superimposed tissue allowing the radiologist to view a mammogram in a way never before possible.

Hologic's clinical trials demonstrated the superior clinical performance of the Selenia® Dimensions® system in combo-mode (2D imaging + 3D imaging) over 2D mammography alone based on ROC analysis.1 The ROC analysis further demonstrated that all radiologists in the clinical studies that Hologic submitted to the FDA demonstrated performance improvement regardless of their level of mammography experience. 1

Hologic's clinical studies reviewed by the FDA, based on ROC analysis, also showed radiologists reading digital mammography (2D) plus breast tomosynthesis (3D) as compared to 2D mammography alone demonstrated superior clinical performance in specificity, the confidence to rule out breast cancer without recalling the patient for further study, and improved sensitivity, the proportion of mammograms with cancer which were correctly diagnosed. 1

The Hologic Selenia Dimensions clinical studies presented to the FDA as part of Hologic's PMA submission that compared Hologic's Selenia Dimensions combo-mode to Hologic's 2D FFDM