FDA Clears CEM Reconstruction and Biopsy Upgrade for Siemens Mammomat Platform

The FDA has cleared a new software platform for Siemens Healthineers' Mammomat mammography devices, adding contrast-enhanced mammography (CEM) image reconstruction and biopsy capabilities directly on the system.

• The clearance covers a new CEM image reconstruction algorithm and associated biopsy workflow tools, integrating the functionality into the Mammomat platform.
• The update streamlines contrast-enhanced spectral mammography exams by consolidating reconstruction and biopsy planning on a single device.
• Specific performance metrics, such as procedure time or biopsy accuracy, were not disclosed in the source.

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