The US Food and Drug Administration has approved Siemens Healthcare’s add-on breast tomosynthesis option for its MAMMOMAT Inspiration digital mammography platform.
Reconstructing multiple two-dimensional images of the breast into an approximation of a three-dimensional image, the company’s breast tomosynthesis algorithm enables detection of tumors that are hidden by overlapping breast tissue. The resulting image represents an improvement over standard 2D digital mammography and can lead to a reduced number of false-positive findings.
In a recent study involving 22 readers with a wide range of reading experience, digital breast tomosynthesis, when read as an adjunct to full-field digital mammography, improved readers’ accuracy in detecting and diagnosing cancers.
When in tomosynthesis mode, the system’s X-ray tube rotates in a circular motion around the breast to acquire an image every two degrees while moving through an angular range of 50 degrees. The resulting 25 projections are reconstructed as 3D digital breast tomosynthesis images.
Conventional analog mammography and full-field digital mammography show the structure of the breast on a 2D level, which can obscure certain types of tumors since anatomical structures in the breast can overlap. On the other hand, tomosynthesis acquires several breast projections from multiple angles. Using raw data to generate a 3D volume set, tomosynthesis allows clinicians to analyze better the type and size of breast lesions, as well as microcalcifications, compared to other forms of mammography. It also increases mammography’s sensitivity and specificity, in addition to improving efforts to differentiate and classify breast tumors.
“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,” said Gregory Sorensen, MD, president and CEO of Siemens Healthcare North America. “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.”
Available on the company’s MAMMOMAT Inspiration and MAMMOMAT Inspiration Prime Edition digital mammography systems, the tomosynthesis option has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia, and South America.
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