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FDA Approves 3-D Digital Mammography System

Hologic Inc., a developer of medical diagnostics and imaging products for women’s health care in Bedford, Massachusetts, says it has received an approval letter from the U.S. Food and Drug Administration (FDA) for the Selenia Dimensions three-dimensional digital mammography tomosynthesis system.

The Selenia Dimensions 3-D system is a new method for breast cancer screening and diagnosis. Breast tomosynthesis produces three-dimensional images which are intended to reveal the inner architecture of the breast, without distortions caused by tissue shadowing or density. Earlier mammography systems generate two-dimensional images.

FDA plans to conduct a review and inspection of Hologic’s manufacturing facility, methods, and controls before granting final pre-market approval of the system. The company says the Selenia Dimensions system is already available commercially outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico.

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