FDA clears breast tomo
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| Screening mammography with breast tomosynthesis in a 57-year-old woman. Image source: RadioGraphics |
Breast tomosynthesis produces 3D images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density. Tomosynthesis images are acquired with the breast held briefly in compression. The examination, which includes a 3D tomosynthesis image in combination with a 2D image, takes slightly longer than a conventional 2D digital mammogram at a total exam dose within current FDA guidelines.
The 3D scan results in a stack of thin high-resolution image slices intended to provide clear rendition of structures in the breast and their spatial relationship with the surrounding breast tissue, according to the company. The images are displayed on a standard diagnostic workstation for review by the radiologist.
Two-dimensional mammography systems have limitations caused by tissue overlapping tissue in the breast that may hide lesions or cause benign areas to appear suspicious. Clinical trials using Dimensions 3D system showed measurable improvement in clinical performance over conventional mammography, significant gains in specificity and other benefits, including improved lesion and margin visibility and the ability to accurately localize structures in the breast, according to Bedford, Mass.-based Hologic.
Dimensions 3D system is available commercially in more than 40 countries and the 3D software is a purchasable option on existing Selenia Dimensions 2D systems without the need for new hardware, according to the company. Upright stereotactic biopsy and computer-aided detection are already cleared for use on Hologic's 2D Dimensions systems.