FDA Approves Hologic’s Selenia Dimensions 3-D System

Bedford, MA based Hologic, Inc. has announced FDA approval of its Selenia Dimensions 3-D system for three dimensional breast imaging. The system was recommended for approval by the FDA’s Radiological Devices Panel this past September, and is now the first 3D breast imaging solution to be FDA approved. Hologic also announced that existing Dimensions 2-D systems can be upgraded to incorporate the new 3D functionality, which uses multiple X-ray views to produce a 3D representation of the patient’s breast.
From the press release:

Unlike prior-generation mammography systems which generate two-dimensional images, breast tomosynthesis 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. Tomosynthesis images are acquired with the breast held briefly in compression. The examination, which includes a 3-D tomosynthesis image in combination with a 2-D image, takes only seconds longer than a conventional 2-D digital mammogram at a total exam dose within current FDA guidelines. The 3-D 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. The images are displayed on a standard diagnostic workstation for review by the radiologist.

Press release: Hologic Receives FDA Approval for First 3-D Digital Mammography (Breast Tomosynthesis) System…
Flashbacks: Hologic 3D Mammography System to be Reviewed by FDA; Hologic’s Selenia Dimensions 3-D Receives Unanimous Recommendation from FDA Advisory Panel