Hologic 3D Mammography

Currently, only one product has been approved by the Food and Drug Administration (FDA) for 3D mammography, the Selenia Dimensions digital breast tomosynthesis system manufactured by Hologic, Inc. This system allows a screening exam to include both the traditional 2D mammogram and the new 3D mammogram. There is very little difference in exam time and in the time their breasts are compressed. Very low X-ray energy is used during the screening examination so the radiation exposure is below the FDA limits.

An independent panel of experts appointed by the FDA deemed Hologic’s technology not only safe and effective for breast cancer screening, but clinically superior to conventional 2D mammography (film or digital) alone.¹ This is the first significant advance in breast screening technology in decades.

Clinical studies using this system have shown many benefits for the patient:

• Breast cancer screening with 3D mammography finds cancers missed with conventional 2D mammography²
• 3D mammography gives radiologists the confidence to significantly reduce recall rates,³ minimizing the anxiety women feel when asked to return for additional tests
• Breast abnormalities such as masses, distortion, and asymmetric densities are better visualized with 3D mammography⁴

These demonstrated benefits may help find and fight breast cancer at its earliest stage, when it is most treatable.

Benefits exclusive to the Hologic Selenia Dimensions digital breast tomosynthesis system.

¹ Hologic, Inc. FDA PMA submission P080003. September 24, 2010.
² Skaane, Per, et. al. “Reading Time of FFDM and Tomosynthesis in a Population-based Screening Program.” Paper presented at the annual meeting of the Radiological Society of North America, Chicago, Illinois, November 29, 2011.
³ Philpotts, Liane, et. al. “Initial Experience With Digital Breast Tomosynthesis in Screening Mammography.” Paper presented at the annual meeting of the American Roentgen Ray Society Annual Meeting, Vancouver, British Columbia, May 3, 2012.
⁴ Bernardi, D, et. al. “Prospective Study of Breast Tomosynthesis as a Triage to Assessment in Screening.” Breast Cancer Research and Treatment 133(1) (Epub 2012): 267-71.