BD secures 510(k) clearance for EnCompass and expands Ypsomed syringe partnership

BDXBDX

BDX gained FDA 510(k) clearance for the EnCor EnCompass breast biopsy system, set for early 2026 launch, enhancing its diagnostic device portfolio. Meanwhile, BDX and Ypsomed are developing a 5.5 mL Neopak XtraFlow syringe compatible with the YpsoMate 5.5 autoinjector, with feasibility samples due mid-2026 targeting large-volume biologics.

1. Partnership Expansion Targets Large-Volume Biologics Market

BD (Becton, Dickinson and Company) has deepened its collaboration with injection-system specialist Ypsomed by developing a 5.5 mL version of its Neopak XtraFlow glass prefillable syringe. The new syringe features an 8 mm needle and thinner-wall cannulas to support higher-volume, high-viscosity biologics and is fully compatible with Ypsomed’s YpsoMate 5.5 autoinjector platform. Samples for feasibility studies are slated for mid-2026 and will allow pharmaceutical partners to accelerate development of combination products while reducing time-to-market for large-dose subcutaneous therapies in oncology, autoimmune and rare diseases.

2. FDA 510(k) Clearance for EnCor EnCompass Breast Biopsy System

BD has secured FDA 510(k) clearance for its EnCor EnCompass breast biopsy system, paving the way for a U.S. launch in early 2026. The system offers clinicians adjustable vacuum levels, real-time tissue sampling feedback and a modular handpiece designed to improve procedural flexibility. Clinical validation studies showed a 25 percent reduction in procedure time versus the prior-generation EnCor system, while maintaining diagnostic accuracy above 95 percent. BD expects EnCor EnCompass to bolster its diagnostic imaging portfolio and drive mid-single-digit revenue growth in its interventional oncology segment next year.

Sources

ZZP