In an April 23 press release, Siemens Healthcare announced it has joined the digital breast tomosynthesis (DBT) market. Receiving FDA approval for its MAMMOMAT Inspiration’s add-on DBT solution, Siemens will increase the opportunity for competition in a market that previously consisted of only two FDA-approved DBT solutions: GE’s SenoClaire and Hologic’s Selenia Dimensions. We have written previously on the need for competition in a long stagnant market in the article “The Evolution of 3-D Tomosynthesis” for ITN magazine.
Although the FDA approval is a new development in the history of the Inspiration system in the United States, Siemens’ tomosynthesis option has been commercially available in Europe, Asia and South America since 2009. With this option, the gantry moves in a 50-degree angular rotation around the breast, acquiring an image every two degrees. This series of images, 25 projections in total, is reconstructed into a 3-D data set that helps radiologist better identify and differentiate areas of concern.
In the press release, Gregory Sorensen, MD, president and CEO of Siemens Healthcare North America said:
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. 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.
Although clinical data is still evolving, studies consistently have proved the benefits of 3-D digital breast tomosynthesis imaging. The June 2014 JAMA study “Breast Cancer Screening Using Tomosynthesis in Combination with Digital Mammography” found a significant improvement in detection and significant decrease in the recall rate when digital mammography and tomosynthesis were used compared to digital mammography alone. Specifically, the study found digital mammography and tomosynthesis use resulted in:
- 41 percent increase in the detection of invasive breast cancers.
- 29 percent increase in the detection of all breast cancers.
- 15 percent decrease in the number of patients called back for additional imaging.
In a separate, internal research effort, Siemens’ study found all 22 participants experienced improved accuracy in the interpretation of mammographic images when DBT was used in conjunction with traditional 2-D imaging. As clinical evidence for Siemens’ add-on solution continues to evolve, we are interested to see how the market receives the MAMMOMAT Inspiration’s newly approved functionality.