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Breast cancer: FDA panel votes to expand PMA for Hologic's mammography system

Fri, 10/26/2012 - 12:41pm
Mass Device

The FDA's Radiological Devices Panel votes to approve expanded indication for Hologic's Selenia 3D digital mammography system.

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The FDA's Radiological Devices Panel this week voted to grant Hologic's (NSDQ:HOLX) expanded approval for its 1st-of-its-kind Selenia Dimensions 3D digital mammography system.

Selenia Dimensions is currently approved for breast cancer screening and diagnosis with full-field digital mammography alone or paired with digital breast tomosynthesis. The company is eying expanded indication that includes use of its new C-View software, which generates synthetic 2D images using digital breast tomosynthesis.

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