FDA Approves High Definition Breast Tomosynthesis From Siemens Healthineers

by Cassling on Apr 6, 2017

New EMPIRE technology applies iterative and machine learning algorithms that provide a clearer, more concise 3D breast reconstruction

mammography.jpgSiemens Healthineers has announced that the Food and Drug Administration (FDA) has approved High Definition Breast Tomosynthesis. This unique form of digital breast tomosynthesis (DBT) includes new cutting-edge algorithms designed to deliver a heightened level of sensitivity to breast cancer detection and diagnosis over 2D mammography alone. 

With products and solutions such as High Definition Breast Tomosynthesis, as well as a new name that underlines the company’s pioneering spirit and engineering expertise, Siemens Healthineers – the separately managed healthcare business of Siemens AG – is helping healthcare providers worldwide meet current challenges and excel in their respective environments.

High Definition Breast Tomosynthesis builds on the established DBT platform from Siemens Healthineers that boasts the industry’s widest tomo sweep of 50 degrees, delivers images of exceptional clarity, and is the first solution approved for 3D-only mammograms. High Definition Breast Tomosynthesis incorporates new EMPIRE (Enhanced Multiple Parameter Iterative Reconstruction) technology, a combination of iterative and machine learning algorithms that provide a clearer, more concise 3D reconstruction.                          

While EMPIRE technology has been approved as a 3D-only exam, it also includes Insight 2D and 3D – the industry’s first synthetic software-generated visualization of tomosynthesis volumes in both 2D and 3D. Insight 2D allows breast imagers to obtain a 2D image from the EMPIRE 3D image set, providing them with a navigational support tool to their 3D-only exams without subjecting patients to added dose. Insight 3D adds new depth to the visualization of the breast anatomy.

“Siemens Healthineers is proud to offer High Definition Breast Tomosynthesis to help our customers increase cancer detection without the need for a 2D image,” said Martin Silverman, Vice President of X-ray Products at Siemens Healthineers North America. “Our new EMPIRE technology can help breast imagers achieve better clarity in both image contrast and detail.”

High Definition Breast Tomosynthesis is available as an option on the company’s Mammomat Inspiration with Tomosynthesis Option digital mammography system.

For further information on High Definition Breast Tomosynthesis, please visit

Siemens contact for journalists: Jeff Bell, Siemens Healthcare; Phone: 610-448-6348; E-mail:    

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 at

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Cassling strengthens community healthcare through customer-centric imaging and therapeutic technology, services and solutions. From critical access hospitals and diagnostic imaging centers to large health systems and IDNs, Cassling is committed to helping healthcare organizations improve access and outcomes, create efficiencies and lower costs.

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