FDA clears first standalone 3D-only screening mammography system

By Staff News Brief


The first standalone 3D-only screening mammography system for use in the United States has been cleared by the U.S. Food and Drug Administration. Siemens Healthineers announced in a press release that the system is the Mammomat Inspiration with Tomosynthesis Option digital mammography system.

A mediolateral oblique view
of the breast obtained using
Siemens’ digital breast
tomosynthesis technology.
Image courtesy Siemens

Two key advantages of a standalone 3D system compared to a 2D + digital breast tomosynthesis (DBT) system is that the number of images to be acquired are half the amount, resulting in an average radiation dose reduction of approximately 40%. A reduction in the number of images to be interpreted can also result in increased workflow efficiency for interpreting mammographers.

3D DBT acquired images will increase diagnostic accuracy as compared to interpretation of 2D + DBT acquired images. Siemens referenced a reader study conducted to determine if malignant lesion detection could be increased at a lower radiation dose than combined 2D and DBT. The study design involved a multi-reader multi-case evaluation of 330 screening full field digital mammography (FFDM) and DBT cases, in which 105 cases showed biopsy-proven malignancies.

All cases were randomly selected from subgroups with specific mammographic characteristics to optimize a distribution similar to that seen in clinical practice. Each case consisted of four-view FFDM and 4 view DBT images. Thirty-one MQSA-qualified radiologists interpreted the 330 cases for both the 2D + DBT and the 3D-DBT acquired images, marking the locations of all suspicious lesions. The cases were randomized for each radiologist. Upon completion of the study, three radiologists compared the findings of the 31 interpreting radiologists with the proven locations of the lesions.

Twenty-nine radiologists, or 93.5% of the total, showed improvement in breast-level ROC areas with DBT. The readers’ mean ROC area with DBT was 0.861 compared to 0.818, the mean ROC area with FFDM. Readers demonstrated an estimated 0.043 improvement in ROC area when reading DBT images compared to FFDM images.

Average recall rates also decreased by an average of 19%. The recall rate of 28 radiologists interpreting DBT images was lower than their recall rate with FFDM alone.

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FDA clears first standalone 3D-only screening mammography system.  Appl Radiol. 

By Staff News Brief| June 07, 2016

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