Siemens Healthcare’s 3D Digital Mammography Platform Gains FDA Approval

April 23, 2015

Siemens Healthcare has won approval for its Mammomat Inspiration with tomosynthesis option, an upgrade for its mammography digital platform, the Malvern, Pa., devicemaker announced Thursday. The company plans an immediate U.S. launch.

The device’s X-ray tube rotates in a circular motion around the breast, capturing 25 images for use in a tomosynthesis algorithm that turns 2D images into a 3D approximation. This 3D modeling allowing for detection of tumors concealed by overlapping tissue, providing more accurate diagnosis than standard 2D digital mammography and limiting false-positive findings, the company says.

The Mammomat Inspiration and Mammomat Inspiration Prime were FDA-cleared in 2010 and 2013, respectively. The Mammomat Inspiration with tomosynthesis option has been available in Europe, Asia and South America since 2009. — Jason Scott