The FDA has voted that Hologic's pre-market approval (PMA) application demonstrated the effectiveness and safety of its Selenia Dimensions 3D digital mammography tomosynthesis system.
The Bedford, Mass.-based developer of women’s healthcare systems said it will work with the FDA on next steps for approval of its Selenia tomosynthesis system, which produces 3D images. While the vote is advisory, the FDA will consider the panel's decision in its final review of Hologic's PMA application for the Selenia Dimensions tomosynthesis system.
"The system is designed to increase accuracy when screening women for the presence of cancerous tissue, and to enable a more precise characterization of suspicious lesions,” explained Jay A. Stein, co-founder and chief technical officer at Hologic. The multicenter clinical study demonstrated that compared to 2D digital mammography alone, 3D digital tomosynthesis used in combination with 2D digital mammography has the potential to reduce recall rates and improve cancer detection, said Hologic.
Hologic's Selenia Dimensions is presently commercially available outside the U.S. In the U.S., Selenia Dimensions is currently available as a 2D only system that can be upgraded to do breast tomosynthesis imaging if the product is approved by the FDA.