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Date set for FDA panel on Hologic's breast tomosynthesis system

by Brendon Nafziger, DOTmed News Associate Editor | July 28, 2010
Selenia Dimensions can be used
for 3-D breast imaging in Europe.
Breast tomosynthesis is a 3-D digital mammography technology some radiologists think can improve the accuracy of mammography. It's already available in Europe. But when will it reach American shores?

The industry might get closer to an answer this fall. On Tuesday, Hologic said the U.S. Food and Drug Administration set aside Sept. 24 as the date it will convene its advisory committee for a panel review of the breast tomosynthesis applications of Hologic's Selenia Dimensions scanner.

The meeting will be part of the pre-market approval submission necessary to clear the technology, Bedford, Mass.-based Hologic said.

Currently, Selenia Dimensions is available with both 3-D and 2-D applications in more than a dozen countries, Hologic said, including parts of Europe, the Middle East, Asia, Australia, Canada and Mexico. In the United States, Selenia Dimensions is a 2-D only system, although it's fully upgradeable to do tomosynthesis if it's cleared by the agency, Hologic said.

Advocates of tomosynthesis say it can help radiologists find cancers they might otherwise miss on conventional 2-D mammography.

"We believe tomosynthesis represents the next phase in breast cancer detection -- fast, high-quality 3-D imaging of the breast," Hologic's president and CEO Rob Cascella said in a statement. "We are thrilled to have a Panel date set for September as an important step in the review of our next-generation technology."

To learn more, read DOTmed's June 2010 industry report on mammography