FDA clears Hologics 3D digital mammo system
Hologic has received an approvable letter from the FDA for the Selenia Dimensions 3D digital mammography tomosynthesis system.

The company noted that final approval of its pre-market approval application for the system “remains subject to satisfactory review and inspection of our manufacturing facility, methods and controls.”

The Bedford, Mass.-based Hologic said that its Selenia Dimensions system is a new method for breast cancer screening and diagnosis. Unlike prior-generation mammography systems which generate 2D images, breast tomosynthesis produces 3D images which are intended to reveal the inner architecture of the breast, the company touted.