FDA Grants Clearance for BD's Innovative EnCor EnCompass™ Breast Biopsy System
FDA Grants Clearance for BD's Innovative EnCor EnCompass™ Breast Biopsy System
On January 15, 2026, BD (Becton, Dickinson and Company) announced a significant milestone: the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System. This advanced multi-modality system is set to revolutionize the biopsy process and enhance breast disease diagnosis for clinicians and patients alike.
A Breakthrough in Breast Health
Rima Alameddine, the worldwide president of Peripheral Intervention at BD, highlighted the importance of this innovation. She emphasized that the EnCor EnCompass™ system enhances breast health by playing a vital role in early detection and diagnosis of breast diseases. "This innovation underscores our commitment to partnering with clinical leaders to deliver patient-centered solutions," she remarked. BD is steadfast in its vision to transform breast health, focusing on technology development that empowers healthcare providers and enhances patient care experience.
Streamlined Procedures for Clinicians
What makes the EnCor EnCompass™ system distinct is its ability to integrate various breast imaging platforms. This capability allows clinicians to perform biopsies with a single, user-friendly system, simplifying the entire procedure. Expected to hit the market in early 2026, the system combines cutting-edge features with a design aimed at improving procedural efficiency.
Stacie Watson, vice president and general manager of the Oncology Platform at BD Interventional–Peripheral Intervention, emphasized the importance of addressing the evolving needs of breast health professionals and patients. "Our platform is engineered for flexibility, control, and ease of use," she noted, adding that these aspects are essential for ensuring a positive patient experience while maintaining clinician confidence.
Innovative Features of the EnCor EnCompass™ System
- - Multi-Modality Usage: Designed to operate seamlessly across various breast imaging modalities, this system caters to the diverse requirements of clinicians.
- - Adjustable Vacuum Strengths: The system offers different vacuum strengths and a variable sample notch that can be fine-tuned during procedures, greatly enhancing control.
- - 360° Sampling Capability: This feature ensures clinicians can access lesions located throughout the breast with ease, allowing for comprehensive diagnostics.
- - Enhanced Visualization: The EnCor EnCompass™ includes an echogenic cutting cannula and an illuminated sample container, improving the visualization of tissue samples during procedures.
- - Variety of Probes: Clinicians can choose from 12G, 10G, and 7G probes tailored to different lesion types and locations, enhancing the system's versatility.
Expert Insights on the New System
Dr. Shadi Aminololama-Shakeri, Chief of Breast Radiology at UC Davis, expressed optimism about the capabilities of the EnCor EnCompass™ system. She stated, "Our goal is always to provide the best possible care for patients while maintaining efficiency, accuracy, and safety. This system combines multi-modality capability and enhanced control into one platform, streamlining the biopsy process."
The clearance of the EnCor EnCompass™ Breast Biopsy System bolsters BD's commitment to advancing breast health technologies and enhancing early detection. This innovative device is a part of BD's broader agenda to improve patient outcomes through cutting-edge medical solutions.
About BD
As one of the largest global medical technology companies, BD is dedicated to advancing healthcare through improved medical discovery, diagnostics, and care delivery. Employing over 70,000 people globally, BD partners with healthcare providers to tackle challenging health issues and facilitate improved patient outcomes. Their innovative technologies serve not only to help clinicians deliver care efficiently but also to empower laboratory scientists and researchers in their vital roles.
For more on BD and their advancements in medical technology, visit their website at bd.com.
Conclusion
The introduction of the EnCor EnCompass™ Breast Biopsy and Tissue Removal System marks a pivotal advancement in breast health technology. By improving flexibility, control, and efficiency, BD remains committed to enhancing the capabilities of clinicians and ultimately benefiting patient care across the healthcare spectrum.
Topics Health）
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