Hologic nets FDA OK for tomo claim in dense breasts

Women's imaging vendor Hologic has received approval from the U.S. Food and Drug Administration (FDA) to claim that its Genius 3D mammography tomosynthesis exam is superior for women with dense breasts.

The FDA on May 23 approved a change to the premarket approval (PMA) labeling for Hologic 3D mammography systems that enables the company to claim that 3D plus 2D imaging has superior accuracy for screening women with dense breast tissue, compared with 2D full-field digital mammography alone. The approval applies to the company's Selenia Dimensions 3D mammography system and Selenia Dimensions with C-View synthesized 2D software module.

The newly approved labeling is based on clinical studies showing that Hologic's 3D digital breast tomosynthesis system enhances invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities, including those with dense breasts, according to the company.

Studies have shown that the Genius 3D exam detects 20% to 65% more invasive breast cancers than 2D mammography alone, with an average increase of 41%, Hologic said.