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Medical Devices / Submissions and Approvals

Hologic's Genius 3D Mammography Exam Gets FDA Clearance

June 8, 2017
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The FDA has cleared Hologic’s Genius 3D mammography exam for routine breast cancer screening of women with dense breasts.

The clearance is based on clinical studies proving that the exam improves invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities, including those with dense breasts.

The new device has been clinically proven to up to 65 percent more invasive breast cancers compared to 2D alone, with an average increase of 41 percent. — Cynthia Jessup

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