March 7, 2017 -- Siemens Healthineers has announced that Health Canada 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 in Canada as a stand-alone screening and diagnostic system
“We are proud to announce the availability of 3D-only screening in Canada,” said Richard Newman, Business Line Manager for X-Ray, Siemens Healthineers Canada. “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 that as a new technology many healthcare institutions will continue using 3D tomosynthesis as an adjunct to 2D screenings. Those providers who use our platform will do so with confidence, knowing our 3D is a proven stand-alone option, whether used with 2D or by itself.”
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.
The study involved the review of over 450 images by 31 Mammography Quality Standards Act (MQSA) certified radiologists and evaluated the accuracy of the readers in detecting and diagnosing malignant lesions using 3D only screening compared to 2D. Of the readers, 29 of the 31 showed improvement in breast-level receiver operating characteristic (ROC) areas.
“The study clearly indicated that the use of Mammomat Inspiration with Tomosynthesis Option digital mammography system leads to additional cancers being detected, as well as a statistically significant decrease in non-cancer recall rate,” continued Richard Newman.
Siemens’ Tomosynthesis Only Option is available on the company’s Mammomat Inspiration and Mammomat Inspiration Prime Edition digital mammography systems.
Further information is available at: https://www.healthcare.siemens.com/mammography/digital-mammography/mammomat-inspiration-prime
Siemens Healthineers is the separately managed healthcare business of Siemens AG enabling healthcare providers worldwide to meet their current challenges and to excel in their respective environments. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services. To help customers succeed in today's dynamic healthcare marketplace, Siemens Healthineers is championing new business models that maximize opportunity and minimize risk for healthcare providers. In fiscal 2016, which ended on September 30, 2016, Siemens Healthineers generated revenue of €13.5 billion and profit of over €2.3 billion and has about 46,000 employees worldwide. Further information is available on the Internet at www.siemens.com/healthineers.
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