Becton, Dickinson and Company announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System, a multi-modality breast biopsy system designed to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease. The EnCor Encompass Biopsy System is designed to streamline the breast biopsy experience by enabling clinicians to perform procedures across a range of breast imaging platforms using one integrated system. The system, which is expected to enter the market in early 2026, offers a combination of advanced features and user-focused design to support procedural efficiency.
Key features of the EnCor EnCompass Biopsy System include: Multi-modality use to support procedures performed across breast imaging platforms; High and low vacuum strengths and a variable sample notch that can be adjusted during the procedure; 360deg sampling capability to access lesions located throughout the breast; Features to enhance visualization, including an echogenic cutting cannula and illuminated sample container; Choice of 12G, 10G, and 7G probes to accommodate different lesion types and locations. The clearance of the EnCor EnCompass Biopsy System expands BD's breast health portfolio and reflects the Company's ongoing commitment to advancing technologies that support early detection and diagnosis.
Becton, Dickinson and Company specializes in the development, manufacturing and marketing of medical and diagnostic equipment and materials. Net sales break down by family of products as follows:
- medical management systems (52.4%): medication delivery systems, pharmaceutical systems, advanced patient monitoring systems, etc.;
- interventional medical equipment (23.9%): surgical instruments, urological care products, etc.;
- diagnostic materials and clinical research and development tools (23.7%): automated systems for blood testing, mycobacteria detection, and molecular biology, medical biology devices, tools for studying genes and culturing cells, instruments for sorting and analyzing cells, monoclonal antibodies, etc.
Net sales are distributed geographically as follows: the United States (58.6%), Europe/Middle East/Africa (21.6%), Asia (14.2%) and other (5.6%).
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