BD’s EnCor EnCompass System Secures the US FDA 510(k) Clearance for Breast Biopsy

Shots:

• The US FDA has granted 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease
• The EnCor EnCompass Biopsy System streamlines breast biopsy procedures by allowing clinicians to use a single integrated system across multiple imaging platforms, with commercial availability expected by early-2026
• The System supports multi-modality breast imaging with adjustable vacuum strengths, a variable sample notch, & 360° sampling for improved lesion access. It also enhances visualization with an echogenic cutting cannula, illuminated sample container, & offers 12G, 10G, & 7G probe options

Ref: PRnewswire  |  Image: BD |  Press Release

Related News: BD Secures the US FDA’s 510(k) Clearance and European CE-IVDR Certification for Enteric Bacterial Panels (EBP) on the BD COR System

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