BD (Becton, Dickinson and Company), a medical technology company, has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its EnCor EnCompass Breast Biopsy and Tissue Removal System. The advanced system is designed to provide clinicians with enhanced flexibility across multiple breast imaging modalities, supporting the diagnosis of breast disease.

According to BD, the EnCor EnCompass Biopsy System represents a significant advancement in breast health by enabling clinicians to perform biopsies using a single, integrated platform across different imaging environments. The system is expected to be commercially available in early 2026.

Rima Alameddine, Worldwide President of Peripheral Intervention at BD, said the FDA clearance marks an important milestone in advancing breast health technologies. She added, “The new system plays a critical role in supporting early detection and diagnosis, while reinforcing our commitment to delivering patient-centred solutions in partnership with clinical leaders.”

The EnCor EnCompass system has been engineered to streamline the breast biopsy workflow by reducing complexity and improving procedural efficiency. Its design allows clinicians to transition seamlessly between imaging modalities without the need for multiple systems, enhancing both clinical confidence and patient experience.

Stacie Watson, Vice President and General Manager of the Oncology Platform at BD Interventional–Peripheral Intervention, said the FDA clearance reflects BD’s focus on meeting the evolving needs of clinicians and patients. She added that the platform offers greater control, ease of use and procedural flexibility to support high-quality breast care.

Key features of the EnCor EnCompass Breast Biopsy and Tissue Removal System include multi-modality compatibility across breast imaging platforms, adjustable high and low vacuum strengths, a variable sample notch that can be modified during procedures and 360 degree sampling capability to access lesions throughout the breast. The system also incorporates enhanced visualisation features such as an echogenic cutting cannula and an illuminated sample container, along with a choice of 12G, 10G and 7G probes to address different lesion types and anatomical locations.

Dr. Shadi Aminololama-Shakeri, Chief of Breast Radiology at UC Davis, said the system supports intraprocedural customisation while maintaining efficiency, accuracy and safety. She highlighted that the multi-modality capability and enhanced control help streamline the biopsy process and improve workflow in clinical practice.