Siemens Healthineers Gets FDA OK for Contrast-Enhanced Mammography, Biopsy

Siemens Healthineers announced it has gained U.S. Food and Drug Administration (FDA) clearance for new contrast-enhanced mammography (CEM) and CEM biopsy capabilities for its Mammomat B.brilliant mammography system.

CEM is an adjunct to mammography that measures contrast uptake differences between healthy and malignant breast tissue to clarify inconclusive findings, assess disease extent, and help radiologists identify suspicious lesions with greater confidence. The company said the system’s new image-reconstruction technique offers clarity and consistency even when examining dense breast tissue.

Mammomat B.brilliant’s ClearCEM image reconstruction enhances lesion visibility and image quality by reducing noise and creating a more uniform background. This helps radiologists identify suspicious areas, supports clinical decision-making, and may reduce additional imaging, unnecessary biopsies, and time to treatment.

If a biopsy is needed after a contrast-enhanced finding, ClearCEM offers a tomosynthesis-guided scout image with targeting accuracy of ±1 mm, potentially speeding diagnosis. Siemens Healthineers said combining scout imaging and tomosynthesis targeting in a single breast compression simplifies the procedure and improves diagnostic confidence.

The new capabilities augment Mammomat B.brilliant’s ability to generate high-resolution 3D mammograms with wide-angle, 50-degree tomosynthesis in under five 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.