Image result for t 3-D MammographyOn Friday, the Food and Drug Administration (FDA) granted approval to Selenia Dimensions digital breast tomosynthesis system marketed by Hologic Inc. of Bedford, Mass., the first such device to be sold in the nation that will produce three-dimensional images of the breast for cancer screening and diagnosis.
According to Hologic, the existing 2-D digital mammography causes about 10 percent of women to undergo additional screening after an initial test, only to detect apparent abnormalities in the breast as benign.
However, the new 3-D breast scanning technology is superior because it can accurately detect cancerous masses hidden by overlying breast tissue.
“Physicians can now access this unique and innovative 3D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jefferey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
Working of Selenia Dimensions System
The Selenia Dimensions System requires 3-D images to be taken in tandem with 2-D images. The examination takes only seconds longer than a conventional 2-D digital mammogram.
The 3-D scan provides a clear version of the structures in the breast and their spatial relationship with the surrounding breast tissue.
The images displayed on a standard diagnostic workstation can then be reviewed by the radiologist.
According to Hologic, the new technology “produces three-dimensional images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density.”
In both the studies, the radiologists found 7 percent improvement in the ability of 3-D images to distinguish between cancerous and non-cancerous tumors, as opposed to viewing 2-D images alone.
Approval on basis of 2 studies
The approval to the system was sanctioned after the health regulators examined the results of two studies, in which radiologists reviewed more than 300 2-D and 3-D images.
In both the studies, the radiologists found 7 percent improvement in the ability of 3-D images to distinguish between cancerous and non-cancerous tumors, as opposed to viewing 2-D images alone.
3-D imaging delivers more radiation
The combination of Selenia’s 2-D and 3-D images delivers double the dose of radiation to patients than standard 2-D mammography and it takes a little more time for radiologists to interpret results.
However, since the 3-D imaging improved accuracy of tumor detection, it cuts the need for women being called for additional diagnostic screening.
The FDA stated, “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 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.”
According to Hologic marketing director Jim Culley, the units cost about $500,000 – $150,000, more than a conventional 2-D machine and will add about $4 to the cost of a mammogram.

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