FDA Approves High Definition Breast Tomosynthesis from Siemens Healthineers

Siemens 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 see www.usa.siemens.com/tomo.