FDA approves new 3D high-definition mammogram
German medical technology firm Siemens Healthineers has received approval from the US Food and Drug Administration (FDA) for high-definition breast tomosynthesis (DBT). The advanced mammogram technique features iterative and machine-learning algorithms which offer improved levels of breast cancer detection. The firm's Enhanced Multiple Parameter Iterative Reconstruction technology is the first approved for 3D-only mammograms.
April 5, 2017 — Siemens Healthineers announced that the U.S. Food and Drug Administration (FDA) has approved High Definition Breast Tomosynthesis. This unique form of digital breast tomosynthesis (DBT) includes new algorithms designed to deliver a heightened level of sensitivity to breast cancer detection and diagnosis over 2-D mammography alone.

High Definition Breast Tomosynthesis builds on the established DBT platform from Siemens Healthineers with what the company calls the industry’s widest tomo sweep of 50 degrees. Siemens also said it delivers images of exceptional clarity, and is the first solution approved for 3-D-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 3-D reconstruction.

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

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

For more information: www.usa.healthcare.siemens.com