The US Food and Drug Administration (FDA) has approved Hologic's Selenia Dimensions System, an X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.
The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts and help physicians more accurately detect and diagnose breast cancer.
As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 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 non-cancerous cases as compared to viewing 2-D images alone.