Siemens’ tomosynthesis add-on lands FDA approval

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The FDA has approved the breast tomosynthesis add-on option for Siemens Healthcare’s MAMMOMAT Inspiration and MAMMOMAT Inspiration Prime Edition digital mammography systems.

Siemens’ tomosynthesis algorithm takes 25 projections, acquired as the digital mammography system rotates in a circular motion with an angular range of 50 degrees, and reconstructs them as a 3D digital breast tomosynthesis image.

Studies have shown that adding tomosynthesis to digital mammography can decrease recall rates and increase cancer detection.

The MAMMOMAT Inspiration with Tomosynthesis Option has been commercially available since 2009 in Europe, Asia and South America, according to Siemens.