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You are here: Home / Regulatory/Compliance / Food & Drug Administration (FDA) / FDA approves Siemens 3D breast tomo device

FDA approves Siemens 3D breast tomo device

April 23, 2015 By Brad Perriello Leave a Comment

FDA approves Siemens breast tomosynthesis device

Siemens Healthcare (NYSE:SI) today said the FDA approved a new breast tomosynthesis option for its Mammomat Inspiration digital mammography device.

Malvern, Pa.-based Siemens Healthcare said its BT algorithm compiles 2-dimensional breast images into a 3-dimensional construct "to enable detection of tumors that are hidden by overlapping breast tissue."

"Our clinical data has demonstrated that the addition of Siemens’ digital breast tomosynthesis to a patient’s traditional 2D digital mammogram increases detection of breast tumors. We know that in clinical practice, this increased diagnostic accuracy also means fewer diagnostic biopsy procedures and fewer anxiety-inducing recalls, which typically contributes to both improved patient outcomes and reduced cost. With the FDA approval of the Mammomat Inspiration with tomosynthesis option, Siemens Healthcare reaffirms its long-standing commitment to cutting-edge innovation in women’s health," Siemens Healthcare North America president & CEO Dr. Gregory Sorensen said in prepared remarks.

Siemens said the Mammomat Inspiration’s X-ray tube rotates around the breast and through an angular range of 50°. The resulting 25 projections are used to construct the 3D digital breast tomosynthesis images, the company said.

The breast tomosynthesis option is available only with the Mammomat Inspiration and Mammomat Inspiration Prime Edition, Siemens said.

Filed Under: Food & Drug Administration (FDA), Mammography, News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Siemens

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