Siemens Healthineers gets FDA nod for CEM on Mammomat B.brilliant

Siemens Healthineers has received U.S. Food and Drug Administration (FDA) clearance for contrast-enhanced mammography (CEM) and CEM biopsy capabilities for the company's Mammomat B.brilliant mammography system.

Mammomat B.brilliant breast imaging systemMammomat B.brilliant breast imaging systemSiemens Healthineers

The new capabilities include ClearCEM, an image reconstruction technique designed to improve lesion enhancement and suppress image noise for more consistent image quality in CEM exams, according to the vendor. For biopsy procedures, ClearCEM provides a scout image for tomosynthesis-guided biopsy with targeting accuracy within plus or minus 1 mm, Siemens highlighted.

The Mammomat B.brilliant offers wide-angle 50-degree tomosynthesis for 3D mammography in under five seconds. The new CEM capabilities are designed to complement this existing functionality, Siemens said.

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