FDA Clears New CEM Image Reconstruction and Biopsy Capabilities for Siemens Healthineers Mammography Device
The Mammomat B.brilliant’s ClearCEM image reconstruction technique reportedly utilizes advanced algorithms to facilitate improved noise reduction and lesion enhancement.
The Food and Drug Administration (FDA) has granted 510(k) clearance for contrast-enhanced mammography (CEM) biopsy and image reconstruction capabilities that have been added to the Mammomat B.brilliant platform.
Employing advanced algorithms, the ClearCEM image reconstruction technique offers a combination of noise suppression and improved lesion enhancement, according to Siemens Healthineers, the manufacturer of the Mammomat B.brilliant platform.
In the event of CEM findings, Siemens Healthineers noted that ClearCEM also facilitates a tomosynthesis-guided biopsy that provides targeting accuracy within 1 mm.
“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, the head of X-ray products at Siemens Healthineers North America.
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