FDA Approves Stand-alone 3D Screening With Siemens Tomosynthesis Platform
May 18, 2016
· In reader study, Mammomat Inspiration with Tomosynthesis Option is first DBT solution to show superior results to 2D as stand-alone 3D exam.
· 3D-only use increases cancer detection and decreases recall rates by an average of 19 percent at a lower dose than DBT combined with 2D.
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.
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Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world's largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of combined cycle turbines for power generation, a major provider of power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2014, which ended on September 30, 2014, Siemens generated revenue from continuing operations of €71.9 billion and net income of €5.5 billion. At the end of September 2014, the company had around 357,000 employees worldwide. Further information is available on the Internet at http://www.siemens.com.