Becton Dickinson Secures FDA 510(k) Clearance for EnCompass Biopsy System, Partners with Ypsomed on 5.5mL Syringe
Becton Dickinson won FDA 510(k) clearance for its EnCor EnCompass breast biopsy system, scheduled for early 2026 launch to boost flexibility and patient care. It also partnered with Ypsomed to develop a 5.5mL Neopak XtraFlow syringe compatible with the YpsoMate 5.5 autoinjector, with feasibility samples due mid-2026.
1. BD and Ypsomed Expand Partnership to Target Growing Biologics Market
BD (Becton, Dickinson and Company) announced on January 21, 2026 that it has enhanced its collaboration with Ypsomed by developing a 5.5 mL version of the BD Neopak™ XtraFlow™ glass prefillable syringe, fully compatible with Ypsomed’s YpsoMate® 5.5 autoinjector platform. The new syringe features an 8 mm needle and a thinner-wall cannula designed to support high-volume, high-viscosity biologics—up to 70 cP—while reducing injection time by as much as 20% compared to standard 12.7 mm thin-wall needles. Feasibility samples will be available in mid-2026, with comprehensive compatibility testing scheduled through year-end, positioning BD to capture a growing subcutaneous self-injection market forecast to exceed $15 billion by 2030. Patrick Jeukenne, worldwide president of BD Pharmaceutical Systems, emphasized that this innovation responds directly to rising demand in oncology, autoimmune and rare-disease therapies, potentially accelerating time-to-market for global pharmaceutical partners.
2. BD Receives FDA 510(k) Clearance for EnCor EnCompass Breast Biopsy System
BD secured FDA 510(k) clearance for its EnCor EnCompass breast biopsy system in late December 2025, paving the way for an early-2026 commercial launch. The system offers a multi-directional, vacuum-assisted tissue acquisition design that delivers up to 12 core samples per procedure with a single insertion, improving patient comfort and procedural efficiency. Clinical validation in a 150-patient multicenter study demonstrated a 35% reduction in procedure time versus leading competitive devices, and a 22% decrease in post-procedure complications. BD’s investor relations team projects incremental annual revenue of $40 million from the EnCompass launch in the first full fiscal year, with potential upside from expanded reimbursement codes in major U.S. markets. The clearance strengthens BD’s diagnostics portfolio and underscores its strategy to diversify revenue streams beyond primary care consumables.