The Food and Drug Administration approved a labeling change to Hologic's Genius 3-D Mammography test.
The labeling change designates the 3-D mammogram as a more effective diagnostic test for women with dense breasts than 2-D mammograms.
"Radiologists and referring physicians needed an answer for how to screen the roughly half of women with dense breasts, because until now, this patient population was confused and frustrated without a clear path forward," Pete Valenti, division president of Hologic's Breast and Skeletal Health Solutions unit, said in a news release.
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