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September 27, 2010

Hologic Screening System Gets FDA Panel Approval

By Matthew L. Brown

Bedford-based Hologic Inc., which has operations in Marlborough, said the U.S. Food and Drug Administration has given pre-approval to the company's 3D digital mammography system.

The preapproval was granted by the FDA's radiological devices panel. The company will now work with the FDA to usher the system to full approval.

The company said the system is designed to detect breast cancer early and with increased accuracy.

The system is already available in Europe, Latin America, Canada and Asia and is only available as a 2D system in the United States.

The radiological devices panel approved the system unanimously.

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