BD has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its EnCor EnCompass™ Breast Biopsy and Tissue Removal System, marking an expansion of the company’s breast health technology portfolio.
The EnCor EnCompass™ system is a multi-modality breast biopsy platform designed to support procedures across different breast imaging technologies using a single integrated system. The device is expected to be commercially available in early 2026.
According to the company, the system is engineered to streamline breast biopsy procedures by offering flexibility across imaging modalities while supporting efficiency and procedural control. It allows clinicians to tailor biopsy procedures in real time and is intended to improve workflow and patient experience during breast disease diagnosis.
Key features of the EnCor EnCompass™ Breast Biopsy System include compatibility with multiple breast imaging platforms, adjustable high and low vacuum strengths, and a variable sample notch that can be modified during a procedure. The system also offers 360-degree tissue sampling to access lesions throughout the breast, enhanced visualization through an echogenic cutting cannula and illuminated sample container, and probe options in 12G, 10G, and 7G sizes to accommodate different lesion types and anatomical locations.
The FDA clearance strengthens BD’s presence in breast health diagnostics and aligns with its focus on technologies that support early detection and accurate diagnosis of breast disease.
