The FDA has approved the use of 3D-only screening mammography for the Siemens Healthineers (formerly Siemens Healthcare) Mammomat Inspiration with Tomosynthesis Option digital mammography system. Unlike mammography systems that offer a combination of 2D and 3D examinations, Siemens’ system is a 3D digital breast tomosynthesis (DBT) platform that’s available as a standalone system.
FDA approval of the 3D-only application follows a reader study in which participating radiologists demonstrated their ability to increase cancer detection at a lower radiation dose than combined 2D and DBT. In the study, radiologists decreased average recall rates by an average of 19% without the need for a 2D image.
Martin Silverman, vice president of Siemens Healthineers’ x-ray products, says the availability of 3D-only screening for company’s Mammomat Inspiration with Tomosynthesis Option digital mammography system is a major milestone in the global imaging sector. “Although this is the first breast tomosynthesis solution on the market to demonstrate statistically superior results to 2D as a standalone breast exam, we know many providers will continue using 3D tomosynthesis as an adjunct to 2D screenings,” he adds. “Those providers who use our platform, however, will do so with confidence, knowing our 3D is a proven standalone option.”
Siemens’ Tomosynthesis Only Option is available on the company’s Mammomat Inspiration and Mammomat Inspiration Prime Edition digital mammography systems.
For more information about this technology, visit Siemens Healthineers.