Siemens Healthineers' Mammomat B.brilliant Gains FDA Clearance for Enhanced Imaging and Biopsy

The Mammomat B.brilliant mammography system by Siemens Healthineers has received clearance from the US Food and Drug Administration (FDA) for its new capabilities in contrast-enhanced mammography (CEM) and CEM-guided biopsies. These advancements are designed to enhance diagnostic precision, especially in dense breast tissue.

The enhanced imaging provided by the Mammomat B.brilliant builds on its existing feature of developing high-resolution 3D mammograms through wide-angle, 50-degree tomosynthesis in less than 5 seconds. This tomosynthesis approach is touted as the widest angle available and is a distinctive attribute of Siemens Healthineers.

Philipp Schmidt, head of X-ray Products at Siemens Healthineers North America, stated, "These new contrast‑enhanced mammography capabilities for the Mammomat B.brilliant reinforce our commitment to delivering greater diagnostic confidence and expanding access to advanced breast imaging techniques."

Contrast-enhanced mammography serves as an adjunct imaging technique, offering additional diagnostic insight compared to traditional mammography by highlighting different contrast uptake levels between healthy and pathological tissue. This allows for more confident diagnosis of suspicious lesions and aids in gauging the extent of disease presence.

The system introduces the new ClearCEM image reconstruction technique, which improves lesion enhancement and ensures consistent image quality. Advanced algorithms within this technique suppress image noise, providing a more homogeneous background. This aids radiologists in accurately identifying and diagnosing potential lesions, potentially facilitating swifter treatment decisions and reducing the need for repeat imaging or unnecessary procedures.

If a biopsy is deemed necessary based on CEM findings, the ClearCEM technology supports tomosynthesis-guided biopsies with a targeting accuracy within ±1 mm, streamlining the diagnostic process. This reduces the time required for diagnosis by integrating scout imaging and biopsy targeting in a single compression sequence.