Mammomat B.brilliant mammography system (Photo:Siemens Healthineers)
June 30, 2026 — The Food and Drug Administration has cleared new contrast-enhanced mammography (CEM) and CEM biopsy capabilities for the Mammomat B.brilliant mammography system from Siemens Healthineers.
The system’s new image-reconstruction technique for CEM exams provides clarity and consistency to boost the confidence of interpreting radiologists, even when examining dense breast tissue, enabling faster diagnosis. These new capabilities build on the Mammomat B.brilliant’s established ability to generate high-resolution 3D mammograms via wide-angle, 50-degree tomosynthesis—the widest angle available and unique to Siemens Healthineers—in less than 5 seconds.1
“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,” said Philipp Schmidt, head of X-ray Products at Siemens Healthineers North America.
Going Beyond Traditional Mammography
CEM is an adjunct breast imaging technique that provides additional information beyond traditional mammography. It measures different levels of contrast uptake between healthy and malignant breast tissue to clarify inconclusive findings and help assess the extent of disease. With this information, the radiologist can identify and characterize suspicious findings with greater confidence.
The Mammomat B.brilliant’s new ClearCEM image reconstruction technique provides improved lesion enhancement and consistent image quality for lesion detection. Its advanced algorithms suppress image noise, generating a more uniform background to help radiologists better identify suspicious areas in breast tissue. This image quality supports clinical decision-making and may enable clinicians to initiate treatment more quickly, while also reducing the need for additional imaging or unnecessary biopsies.
If the patient requires a biopsy following a contrast-enhanced finding, the procedure is typically performed using contrast. ClearCEM provides a scout image for tomosynthesis-guided biopsy that permits targeting accuracy within ±1 mm, potentially reducing time to diagnosis. The combination of ClearCEM-powered scout imaging and tomosynthesis-based targeting within the same breast compression sequence simplifies the biopsy procedure and can improve diagnostic confidence
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Data on file. For average breast size of 50/50 glandular/adipose tissue and 5 cm thickness.
September 15, 2026 
