FDA Approves Stand-alone 3D Screening With Siemens Tomosynthesis Platform

Siemens Healthineers has announced that the Food and Drug Administration (FDA) has approved the use of 3D-only screening mammography utilizing the company’s Mammomat Inspiration with Tomosynthesis Option digital mammography system. The Siemens system is the first and only 3D digital breast tomosynthesis (DBT) platform to be approved by the FDA as a stand-alone screening and diagnostic system; all other mammography systems on the market require a combination of 2D and 3D examinations.

FDA approval of the 3D-only application follows a pivotal 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 percent without the need for a 2D image.

“Siemens is proud to announce the availability of 3D-only screening with our Mammomat Inspiration with Tomosynthesis Option digital mammography system,” said Martin Silverman, Vice President of X-ray Products at Siemens Healthineers. “Although this is the first breast tomosynthesis solution on the market to demonstrate statistically superior results to 2D as a stand-alone breast exam, we know many providers will continue using 3D tomosynthesis as an adjunct to 2D screenings. Those providers who use our platform, however, will do so with confidence, knowing our 3D is a proven stand-alone option.”

Siemens’ Tomosynthesis Only Option is available on the company’s Mammomat Inspiration and Mammomat Inspiration Prime Edition digital mammography systems.