FDA Grants 510(k) Clearance to EnCor EnCompass™ Biopsy System, Launch Early 2026
Becton Dickinson received FDA 510(k) clearance for its EnCor EnCompass™ breast biopsy and tissue removal system, designed for multi-modality imaging with 360° sampling and variable vacuum strengths. The device, slated for market launch in early 2026, expands BD’s breast health portfolio and could drive future sales growth in diagnostic interventions.
1. BD Receives FDA 510(k) Clearance for EnCor EnCompass Breast Biopsy System
On January 15, 2026, BD announced that the U.S. Food and Drug Administration granted 510(k) clearance for its EnCor EnCompass™ Breast Biopsy and Tissue Removal System, a state-of-the-art multi-modality platform designed to streamline tissue acquisition across ultrasound, stereotactic and tomosynthesis imaging. The system is slated for commercial launch in early 2026 and features adjustable high and low vacuum strengths, a variable sample notch that can be modified mid-procedure, 360° sampling capability and an echogenic cutting cannula paired with an illuminated specimen container. Clinicians can choose among 12G, 10G and 7G probes to target lesions of varying size and location. According to BD’s worldwide president of Peripheral Intervention, Rima Alameddine, the EnCompass system underscores the company’s commitment to early detection of breast disease and is expected to support more than one million biopsy procedures annually in the U.S. The clearance expands BD’s breast health portfolio—already responsible for over 20% of the company’s interventional revenues—and reinforces its position in the $1.2 billion global image-guided biopsy market.
2. BD Names Shawn Bevec Senior Vice President of Investor Relations
Effective January 20, 2026, BD has appointed Shawn Bevec as Senior Vice President of Investor Relations, reporting to interim CFO Vitor Roque. Bevec joins BD from Quest Diagnostics, where he served as Vice President of Investor Relations and led quarterly earnings communications and capital markets engagement. His background includes six years as a sell-side analyst at Deutsche Bank and Susquehanna International Group covering medical devices and health care services, as well as research and development roles at Pfizer and Johnson & Johnson. Bevec holds a B.Sc. in Chemistry from the University of Arizona and an MBA from NYU’s Stern School of Business. Roque stated that Bevec’s deep expertise will be instrumental in articulating BD’s long-term growth strategy and driving shareholder value across BD’s four core segments—medical essentials, connected care, biopharma systems and interventional solutions.