The FDA approved the Selenia Dimensions System, the first X-ray mammography device that provides 3-D images of the breast for breast cancer screening and diagnosis.
With the limitations of conventional 2-D imaging, about 10% of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.
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. The 3-D images may help physicians more accurately detect and diagnose breast cancer.
“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, stated in a press release.
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.
While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5% compared to the natural cancer incidence, and less than 1% compared to the risk from conventional 2-D mammography.