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# Hologic Gains Approval for Genius 3D Mammography Superiority
- URL: https://www.fdaweb.com/hologic-gains-approval-for-genius-3d-mammography-superiority/
- Published: 2017-06-07T12:00:00.000Z
- Updated: 2026-09-14T22:27:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138879

FDA has approved a Hologic PMA supplement for the Genius 3D Mammography exam and its use being superior to standard 2D mammography for routine breast cancer screening of women with dense breasts. The device has been available in the U.S. since 2011, and the newly approved physician labeling is based on clinical studies demonstrating that the exam improves invasive breast cancer detection among women of all breast densities, including those with dense breasts, according to the company. The device was shown to detect 20 to 65% more invasive breast cancers compared to 2D alone, with an average increase of 41%, it says. Between 40-50% of women aged 40 to 74 have dense breasts.