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Gus Iversen, Editor in Chief | July 01, 2026
Siemens Healthineers has received FDA clearance for new contrast-enhanced mammography (CEM) and CEM-guided biopsy capabilities on its Mammomat B.brilliant mammography system.
The Malvern, Pennsylvania-based company's newly cleared features include a CEM image reconstruction technique called ClearCEM, which is designed to improve image quality and lesion visualization during contrast-enhanced breast imaging. The company said the technology is intended to support interpretation of exams, including in patients with dense breast tissue.
CEM is used as an adjunct to conventional mammography, providing additional information by measuring differences in contrast uptake between healthy and potentially malignant breast tissue. The technique can help radiologists further evaluate inconclusive findings and assess the extent of disease.
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According to Siemens Healthineers, the ClearCEM reconstruction algorithm reduces image noise and produces a more uniform background, making suspicious lesions easier to identify. The company said the improved image quality may help support clinical decision-making and reduce the need for follow-up imaging or unnecessary biopsies, although those outcomes will depend on individual clinical circumstances.
The FDA clearance also covers CEM-guided biopsy capabilities. When a biopsy is needed after a contrast-enhanced exam, the system uses a ClearCEM-generated scout image with tomosynthesis-guided targeting. Siemens Healthineers said the approach enables targeting accuracy within ±1 millimeter while allowing imaging and targeting to be completed during the same breast compression sequence.
The new capabilities build on the Mammomat B.brilliant platform, which previously introduced wide-angle, 50-degree breast tomosynthesis. Siemens Healthineers says the system produces high-resolution 3D mammograms in less than 5 seconds.
“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.
