Hologic 3D Mammography exam achieves FDA milestone

The U.S. Food and Drug Administration (FDA) has approved a change to the physician labeling of the Hologic Selenia Dimensions 3D system with C-View software module to claim superior screening accuracy of 3D plus 2D imaging as compared to full-field digital mammography alone for women with dense breasts.

“The Genius™ 3D Mammography™ exam is now the only mammogram that is FDA-approved as superior to standard 2D mammography for routine breast cancer screening of women with dense breasts,” the company stated in a press release. The Genius exam has been commercially available in the United States since 2011.

The newly approved physician labeling is based on clinical studies that proved the exam improved invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities including those with dense breasts. The clinical studies showed that 20% to 65% more invasive breast cancers could be detected compared to 2D mammography alone, with an average increase of 41%.

The Genius 3D Mammography exam is only available on a Hologic® 3D Mammography™ system. It consists of a 2D and 3D image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D image set.