FDA Approves Silenia Dimensions 3-D Mammography System


Mammography is an important diagnostic tool that assesses cancerous growth in breast.  As per National Cancer Institute about 200,000 women will be diagnosed with breast cancer this year. Mammography can increase survival rate as much as by 98% when breast cancer is detected early and still localized to the breast.  The Food and Drug Administration (FDA) approved the first three-dimensional mammography system developed by Hologic Inc.  The device is known as the Silenia Dimensions System.

How does Hologic’s 3-D mammography system work?
The Silenia Dimensions System augments traditional two-dimensional images produced by a mammogram with a three-dimensional image to be used in breast-cancer screening and diagnosis. Doctors have option of looking at 3-D and 2-D (conventional images) to diagnose the problem. 

What is major limitation of a conventional mammogram?

Conventional mammogram is a 2-D imaging technique, which causes the overlap of breast tissue on the image.  This can obscure small tumors. As per estimation from FDA ~10% of women undergoing a mammogram are called back for additional testing for abnormalities that are noncancerous.


How can Silenia Dimension 3-D imaging system help?
Design of Hologic’s 3-D device can facilitate

  • produce clearer images of the breast
  • potentially make breast cancer easier to diagnose
  • reduce the number of women who are called back for...

    additional screening after undergoing a conventional mammogram

 The FDA said the 3-D images “may help physicians more accurately detect and diagnose breast cancer.”

Does Hologic have clinical data from 3-D mammogram?  
Hologic conducted two studies, in which radiologists were asked to review both 2-D and 3-D images from more than 300 mammograms. FDA reviews the data and commented that the studies showed doctors obtained a 7% improvement in their ability to distinguish between cancerous and noncancerous cases using the 3-D images compared to viewing 2-D images alone.


Is there any limitation with 3-D mammography?
The FDA acknowledged that the 3-D system increases the radiation dose women receive compared to a traditional mammogram.  Although, no significant concerned was quoted with increased radiation.



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