BD Receives FDA Approval for Innovative EnCor EnCompass Breast Biopsy System
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The US Food and Drug Administration (FDA) has granted 510(k) approval to Becton, Dickinson and Company (BD) for its EnCor EnCompass breast biopsy and tissue removal system, poised to streamline procedures and enhance diagnostic flexibility for clinicians.
The encor EnCompass system represents a significant advancement in breast health technology, offering a multi-modality platform designed to work seamlessly across various breast imaging modalities. This integration aims to simplify the biopsy process and improve the accuracy of breast disease diagnosis.
Streamlining biopsy Procedures with a Multi-Modality Approach
BD anticipates launching the EnCor EnCompass system in early 2026, emphasizing its features designed to maximize procedural efficiency. The system is engineered to support use across diverse breast imaging platforms within a single, integrated device, reducing complexity for medical professionals.
Key technical specifications of the encor EnCompass system include a variable sample notch adjustable during procedures, compatibility with a range of imaging platforms, both high and low vacuum strength options, an echogenic cutting cannula for enhanced visualization, and 360° sampling capability. Furthermore, the system offers probe options of 10G, 7G, and 12G to accommodate various lesion types, and features an illuminated sample container for improved sample assessment.
Expanding BD’s Commitment to Breast Health
The FDA clearance expands BD’s portfolio of breast health technologies and reinforces the company’s dedication to early detection and diagnosis. according to a company release, the EnCor EnCompass system plays “a critical role in aiding the early detection and diagnosis of breast disease.”
“This milestone for our new breast biopsy system marks a meaningful advancement in breast health,” stated a senior official at BD. “this innovation underscores our commitment to partnering with clinical leaders to deliver patient-centred solutions. Guided by our vision to transform breast health,we remain focused on developing technologies that empower providers and inspire confidence in care.”
Stacie Watson, vice president and general manager of BD’s interventional-peripheral intervention oncology platform, added, “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. 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.”
Investment in Manufacturing Capacity
In August 2025, BD announced a more than $35 million investment to expand manufacturing capacity for its BD PosiFlush prefilled flush syringes at its facility in Columbus, Nebraska. This expansion demonstrates BD’s commitment to meeting the growing demand for its products and supporting healthcare providers.
the EnCor EnCompass system represents a significant step forward in breast biopsy technology, promising to improve diagnostic accuracy and streamline procedures for clinicians, ultimately benefiting patients through earlier and more effective breast cancer detection and treatment.
Why: BD received 510(k) FDA approval for its EnCor EnCompass breast biopsy system to improve diagnostic accuracy and streamline procedures.
Who: Becton,Dickinson and Company (BD) developed the system,and the FDA granted the approval. Clinicians and patients are the primary beneficiaries.
What: The EnCor EnCompass system is a multi-modality breast biopsy and tissue removal system.
How did it end?: BD anticipates launching the system in early 2026 and has already invested $35 million to expand manufacturing capacity for related products,demonstrating a commitment to meeting future demand.
