FDA Approves Genius 3D Mammography: Best Exam for Women with Dense Breasts

by PJ Hamel Patient Expert

On June 12, 2017 the Food and Drug Administration (FDA) granted approval to the Genius 3D Mammography Exam “as superior to standard 2D mammography for routine breast cancer screening of women with dense breasts.” This marks the first digital tomosynthesis system (a.k.a. 3D mammogram) so approved.

A 2014 study showed that 3D exams used in concert with standard mammograms identify about 40 percent more invasive cancers than standard 2D mammograms alone in women with dense breasts — great news for the 40 to 50 percent of women who have dense breasts. With FDA approval, the number of facilities offering 3D exams should show solid growth.

How does 3D mammography work?

The standard mammogram sends X-rays through your breast, recording results either on film or in digital format. The radiologist then examines the film (or computer image), looking for solid masses that aren’t normal tissue nor fat, masses that show up white or light gray on the image.

With 3D mammography, the breast is X-rayed from a series of different angles, and then all of the data is reconstructed digitally into a 3D image, giving the radiologist a much clearer and more thorough view of your breast.

With traditional mammography, scar tissue, a fold of compressed flesh, or other normal parts of the breast can appear suspicious, calling for additional views and/or tests. With 3D, it’s easier for radiologists to either rule out an anomaly without a callback; or rule it in, necessitating a biopsy. Either way, the woman endures less uncertainty, less waiting, and fewer additional tests.

Most effective screening tool for women with dense breasts

3D mammography is especially valuable for women with clinically dense breasts. It’s estimated traditional mammograms are only about 50 percent effective for these women because the white appearance of a solid mass detected by X-ray can easily be hidden by the same white appearance of normal fibrous and glandular tissue.

Do you have dense breasts?

Thirty-one states require doctors to notify their patients if they have dense breasts. But if you’ve had a mammogram, and don’t know — just ask your doctor. It’s important information, given that women with dense breasts are up to six times more likely to be diagnosed with breast cancer than the average woman.

Interested in having a 3D mammogram? Find a facility offering the Genius 3D exam near you.


"Mammograms." National Cancer Institute. Accessed July 07, 2017. https://www.cancer.gov/types/breast/mammograms-fact-sheet.

PJ Hamel
Meet Our Writer
PJ Hamel

PJ Hamel is senior digital content editor and food writer at King Arthur Flour, and a James Beard award-winning author. A 16-year breast cancer survivor, her passion is helping women through this devastating disease. She manages a large and active online survivor support network based at her local hospital and shares her wisdom and experience with the greater community via HealthCentral.com.