FDA clears Hologics 3D digital mammo system

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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.