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Medical Devices / Submissions and Approvals

Hologic Wins FDA Clearance for Breast Density Software

Nov. 29, 2017
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The FDA cleared Hologic’s Quantra 2.2 breast density assessment software for marketing.

The Quantra software uses an algorithm that can provide four categories of density assessments to clinicians performing routine breast cancer screenings.

The device helps clinicians detect breast cancer in women with very dense breasts — who are up to five times more likely to develop the disease.

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