GE seeks FDA approval for 3-D mammography add-on

by Brendon Nafziger, DOTmed News Associate Editor | November 11, 2011
GE Healthcare has moved one step closer to entering the 3-D mammography market. The company said Thursday it submitted the first part of its application to the Food and Drug Administration for a new add-on that would allow its existing digital Senographe Essential units to offer breast tomosynthesis.

In breast tomosynthesis, the device sweeps around the breast taking X-rays, which the unit uses to generate a 3-D image of the breast. Advocates of the technology say it could help detect lesions hidden in 2-D mammography by overlapping tissue.

GE said there's already a substantial user base for the Senographe Essential, a full-field digital mammo system, with at least 1,200 machines installed in the United States.

For now, the Waukesha, Wis.-based division of the electronics giant said it has given the FDA the first "module" of its pre-market approval application, including non-clinical data, such as from phantom testing and detector performance. This "modular" approach lets the company submit sections of the application piecemeal. This way, GE can respond to FDA concerns earlier in the approval process, the company said. GE expects to file three more modules over the coming year.

When contacted by DOTmed News, GE said it couldn't comment on the process or plans for an international release.

Hologic Inc. was the first, and so far only, company to release a clinical breast tomosynthesis unit in the United States. Its device, the Selenia Dimensions digital breast tomosynthesis system, received FDA clearance in February. Siemens has also developed the technology, for its MAMMOMAT Inspiration, but it's only available in Europe.

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