Hologic’s Selenia Dimensions 3-D Receives Unanimous Recommendation from FDA Advisory Panel

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