BD Wins FDA Nod for EnCor Encompass Breast Biopsy and Tissue Removal System

BD (Becton, Dickinson and Company) has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its EnCor Encompass breast biopsy and tissue removal system.

EnCor Encompass is a multi-modality breast biopsy system. It’s designed to offer clinicians flexibility across breast imaging modalities to diagnose breast disease.

The system was engineered to streamline the breast biopsy process by letting clinicians perform procedures on a range of breast imaging platforms using a single integrated system. The system is expected to enter the market in early 2026—it provides a combination of advanced features and user-focused design to support procedural efficiency.

EnCor Encompass features high and low vacuum strengths and a variable sample notch that can be adjusted during a procedure. It has 360-degree sampling capability to access lesions throughout the breast as well as features to enhance visualization, including an echogenic cutting cannula and illuminated sample container.

Clinicians have a choice of 12G, 10G, and 7G probes to accommodate different lesion types and locations.

“The FDA clearance of the EnCor EnCompass Biopsy System demonstrates our ongoing focus on addressing the evolving needs of clinicians and patients in breast health,” said Stacie Watson, vice president and general manager of the Oncology Platform at BD Interventional–Peripheral Intervention. “This multi-modality platform is engineered to provide flexibility, control, and ease of use, with features designed to support both clinician confidence and the patient experience.”

“Our goal is always to provide the best possible care for patients while maintaining efficiency, accuracy, and safety,” added Dr. Shadi Aminololama-Shakeri, MD, chief of breast radiology at UC Davis. “The EnCor EnCompass Biopsy System combines multi-modality capability and enhanced control into one platform that supports intraprocedural customization and helps streamline the biopsy process.”