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Healthcare giant Siemens (NYSE: SI) this week filed its premarket approval application to get the FDA’s OK to add a tomosynthesis option to its Mammomat Inspiration mammography system.
The breast tomosynthesis mode captures a range of angled pictures of tissue to produce a 3D image of the breast tissue, combining that with 2D images to provide a more robust view that can help clinicians better detect and diagnose breast cancer.
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The 3D images (pictured left) allow for more reliable diagnoses, regardless of breast size or tissue density, when compared to the 2D images (pictured right).
The X-ray tube moves through a 50° arc above the stationary detector, acquiring an image every two degrees for a total of 25 projections.
The projection images are then reconstructed into a 3D volume in DICOM format for flexible display on reading and reporting workstations.
However, Hologic has faced hurdles in reimbursement for tomosynthesis and analysts have warned that mammography faces market hurdles that have slowed down usage.
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We're taking the standard 2D mammography image and then, rather than just having that single view of the breast, we are actually dividing it into multiple slices." The ability to view multiple layers of breast tissue at different depths makes tomosynthesis more sensitive and specific than conventional two-dimensional mammograms.
"We are now able to take images of the breast at multiple points, rather than the standard two-dimensional view, akin to reviewing slices of bread rather than looking at the whole loaf from one view.