FDA clears contrast-enhanced mammography, biopsy features for breast imaging system
The U.S. Food and Drug Administration recently cleared new contrast-enhanced mammography (CEM) and CEM biopsy features for one of Siemens’ Healthineers' imaging systems.
The 510(k) clearance pertains to the company’s Mammomat B.brilliant mammography scanner. The new features will complement the system’s wide-angle, 50-degree tomosynthesis—the largest available—3D imaging capabilities, offering radiologists enhanced visualization of breast tissue, which is critical for analyzing imaging of women with highly dense breasts.
The system’s new ClearCEM image reconstruction technique is behind the enhanced visualization. Its advanced algorithms suppress image noise, which creates a more uniform background appearance and, in turn, makes it easier to spot suspicious lesions.
For biopsies, ClearCEM provides a scout image for tomosynthesis-guided biopsy that enables targeting accuracy within 1 mm, according to Siemens. Leaders at the company are hopeful the combination of contrast-enhanced imaging and precision lesion targeting capabilities will improve diagnostic confidence and patient care.
“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,” Philipp Schmidt, head of X-ray Products at Siemens Healthineers North America, said in an announcement on the clearance.
Interest in CEM has seen significant growth in recent years as more clinical evidence supporting its use has come to light. The most recent update to the Breast Imaging Reporting and Data System (BI-RADS) manual reflects this trend, as a CEM section was added to the 2025 release.
In the U.S., CEM is approved for use as a diagnostic tool but not in screening. However, similar to some other countries, this has not stopped providers from utilizing it in patients who would benefit from contrasted imaging. Many believe that more widespread reimbursement for the modality is on the horizon.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.