Hologic, Inc. of Bedford, MA has received unanimous recommendation for approval from the Radiological Devices Panel of the FDA for the Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System. The system, which we have covered previously, uses multiple low-energy X-ray shots to produce 3-D images of the breast. Viewing a three-dimensional structure in 3-D has obvious advantages, and data from the multicenter clinical study indicate that 3-D digital tomosynthesis has the potential to improve cancer detection and reduce recall rates.
Although a favorable vote is only advisory in nature, the FDA regularly follows the recommendations of these panels. Selenia Dimension systems are currently available in the USA in 2-D versions, and these systems may be upgraded to 3-D if FDA approved.
Press release: Hologic’s Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System Receives Favorable Votes
Flashback: Hologic 3D Mammography System to be Reviewed by FDA