Breast Tomosynthesis: 3-D Mammography Reaches the U.S. Market

August 8, 2017 | Evaluations & Guidance


On February 11, 2011, Hologic’s Selenia Dimensions 3-D system became the first device to receive FDA premarket approval (PMA) for breast tomosynthesis applications. The approval of this system—which is a modification of Hologic’s Selenia Dimensions 2-D system—will likely pave the way for the approval of breast tomosynthesis technology from other manufacturers.

Breast tomosynthesis has the potential to reduce the number of missed cancers and the number of patients unnecessarily recalled for repeat studies compared to standard 2-D mammography. While 2-D mammography obtains only a simple projection through a patient, breast tomosynthesis combines multiple 2-D images taken during a single sweep to produce slices that are less affected by overlying anatomy. But despite its potential advantages, there are still many issues that may limit widespread clinical adoption, including an increased radiation dose to most patients, increased costs to healthcare facilities, and a current lack of insurance reimbursement.

Today, 2-D mammography is the primary technology used to screen for breast cancer. During a 2-D mammographic procedure, two views of each breast are acquired to help localize any lesions: the mediolateral oblique (MLO) view and the craniocaudal (CC) view. If the resulting images are unclear, or if they show signs of cancer, then patients will be recalled for further studies, possibly including more targeted mammography studies. If, after these studies, cancer is suspected and...

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