FDA clears contrast-enhanced mammography and biopsy on a breast imaging system

FDA cleared a breast imaging system with contrast-enhanced mammography (CEM) and biopsy capabilities, broadening access to CEM as clinical evidence supporting its use grows.

• The clearance adds CEM and biopsy functionality to an existing breast imaging platform (vendor unspecified in source).
• Interest in CEM has increased with accumulating clinical evidence, though no specific performance data were required for this clearance.

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