Approval in China
Siemens Healthcare has received approval from the CFDA for the Mammomat Inspiration with the True 3D Breast Tomosynthesis* option. Siemens is the first to receive approval for Breast Tomosynthesis in China. In order to receive approval, Siemens Healthcare has provided the CFDA with clinical study results and manufacturing information.
How tomosynthesis works
The True 3D Breast Tomosynthesis option has been designed as an add-on option for the digital mammography system Mammomat Inspiration. In Tomosynthesis mode, Mammomat Inspiration acquires 25 projection views over an angular range of 50 degrees to produce 3D digital breast Tomosynthesis (DBT) images, intended to be suitable for screening and diagnosis of breast cancer.
Whereas conventional 2D mammography produces a single projection breast image, DBT acquires and combines breast images from multiple angles to create a 3D rendering of the entire breast. This is displayed in slices to reduce the impact of overlapping breast tissue. This enables tumors that may covered by overlapping tissue in conventional 2D mammography to be displayed. Currently breast Tomosynthesis is performed together with 2D mammography on the same system.
True 3D Breast Tomosynthesis has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia and South America. In the U.S., Siemens recently submitted to the U.S. Food and Drug Administration (FDA) its premarket approval application (PMA) for Mammomat Inspiration with Breast Tomosynthesis option.
Tomosynthesis is not commercially available in all countries. Due to regulatory reasons its future availability cannot be guaranteed. Please contact your local Siemens organization for further information.