The Wall Street Journal (2/12, Dooren) reported that the FDA on Friday announced it has approved a mammography device by Hologic Inc. The Selenia Dimensions System is the first device with the ability to generate three-dimensional images of the breast to be approved in the US. The agency expects that 3-D system will reduce the number of women who are called back for additional screening. Currently, about 10% of the women who receive mammograms are called back for additional testing because of unclear readings and false-positives in their original set of mammograms, according to FDA estimates.
According to the Boston Globe (2/12, Weisman), the Selenia device is based "digital tomosynthesis, which can see through overlapping tissue often obscured in two-dimensional scans." The AP (2/14) adds that although the system "doubles the radiation exposure" for patients, the FDA emphasized that it also "increases" diagnosis accuracy. The agency approved the device based on "two studies" that demonstrated a "7-percent improvement in spotting cancerous tumors when viewing images from Hologic's device, compared with traditional 2-D images. … 'Physicians can now access this unique and innovative 3-D technology that could significantly enhance diagnosis and treatment approaches,'" said FDA's Center for Devices and Radiological Health Director Jeffrey Shuren. The Selenia device is "already approved in Europe, Latin America and Asia."
The Los Angeles Times (2/12, Zajac) noted that although the technology will "presumably reduce" the number of inconclusive initial mammograms, it is unclear whether the device would ultimately reduce the rate of breast cancer mortalities. Carol Lee, M.D., who chairs the American College of Radiology's Committee on Breast Imaging, "said it's too early to tell how useful the technology will be." It has not yet been shown whether 3-D scanning can pinpoint "more cancers," Dr. Lee said.
Meanwhile, HealthDay (2/13) reports that currently, about "200,000 women" are diagnosed with breast cancer each year, and one in eight women "will face a diagnosis of breast cancer sometime during their lifetime," according to NCI data. Reuters(2/14, Heavey), CNN (2/11, Caruso) in its "The Chart" blog and MedPage Today (2/13) also reported FDA's approval of the 3-D scanning device.