BD Receives FDA Clearance for Multi-Modality Breast Biopsy System, Market Launch Planned for Early 2026
核心洞察
BD (搜索) received FDA 510(k) clearance for its EnCor EnCompass Breast Biopsy and Tissue Removal System (搜索), a state-of-the-art multi-modality platform designed to enhance breast disease (搜索) diagnosis.
The system features advanced capabilities including high and low vacuum strengths, 360-degree sampling ability, and multiple probe options to accommodate different lesion types across various breast imaging modalities.
The device is expected to enter the market in early 2026, expanding BD (搜索)'s breast health portfolio and supporting early detection and diagnosis of breast disease (搜索).
BD (搜索) (Becton, Dickinson and Company) announced that the U.S. Food and Drug Administration (搜索) has granted 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System (搜索), marking a significant advancement in breast health technology. The state-of-the-art multi-modality breast biopsy system is designed to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease (搜索) and is expected to enter the market in early 2026.
Advanced Multi-Modality Platform
The EnCor EnCompass Biopsy System is engineered to streamline the breast biopsy experience by enabling clinicians to perform procedures across a range of breast imaging platforms using one integrated system. According to Rima Alameddine, worldwide president of Peripheral Intervention at BD (搜索), "This milestone for our new breast biopsy system marks a meaningful advancement in breast health, playing a critical role in aiding the early detection and diagnosis of breast disease (搜索)."
The system incorporates several advanced features designed to support procedural efficiency and clinical flexibility. Key capabilities include high and low vacuum strengths with a variable sample notch that can be adjusted during the procedure, providing clinicians with enhanced control throughout the biopsy process. The device also offers 360-degree sampling capability to access lesions located throughout the breast, addressing the diverse anatomical challenges encountered in breast biopsies.
Enhanced Visualization and Probe Options
To improve procedural accuracy and efficiency, the EnCor EnCompass system includes features designed to enhance visualization, including an echogenic cutting cannula and illuminated sample container. The platform offers a choice of 12G, 10G, and 7G probes to accommodate different lesion types and locations, allowing clinicians to tailor their approach based on specific clinical requirements.
Dr. Shadi Aminololama-Shakeri, Chief of Breast Radiology at UC Davis (搜索), emphasized the clinical value of the system's integrated approach: "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."
Clinical Applications and Safety Profile
The EnCor EnCompass Breast Biopsy and Tissue Removal System (搜索) is indicated to acquire breast tissue for histologic examination with partial or complete removal of the abnormality. The device is designed for use across multiple breast imaging modalities, providing clinicians with a unified platform for various procedural approaches.
As with any medical device, the system has specific contraindications and potential complications. The device is contraindicated for patients where there is an increased risk of complications associated with percutaneous removal of tissue samples, as determined by physician judgment. Potential complications include hematoma, hemorrhage, hemothorax, pneumothorax, surgical intervention, infection, adjacent tissue injury, pain, allergic reaction, and tissue adherence to the biopsy probe during removal from the breast.
Strategic Portfolio Expansion
The FDA clearance of the EnCor EnCompass Biopsy System expands BD (搜索)'s breast health portfolio and reflects the company's ongoing commitment to advancing technologies that support early detection and diagnosis. Stacie Watson, vice president and general manager of the Oncology Platform at BD Interventional–Peripheral Intervention, noted that "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."
The system's development aligns with BD (搜索)'s broader vision to transform breast health through innovative technologies that empower healthcare providers and inspire confidence in patient care. The company's focus on addressing the evolving needs of clinicians and patients in breast health is demonstrated through this latest technological advancement, which combines multiple procedural capabilities into a single, integrated platform.