The U.S. Food and Drug Administration granted 510(k) clearance to Becton, Dickinson and Company’s EnCor EnCompass™ Breast Biopsy and Tissue Removal System on January 15 2026, allowing the device to be used across a range of breast imaging modalities. The clearance removes a regulatory hurdle that had delayed the product’s market entry and positions BD to capture early adoption in the breast health market.
The EnCor EnCompass™ system is a multi‑modality platform that integrates biopsy and tissue removal into a single workflow. It offers 12‑, 10‑, and 7‑gauge probes, variable vacuum strengths, a 360‑degree sampling capability, an illuminated sample container, and an echogenic cutting cannula. These features streamline the procedure, reduce the number of instruments required, and give clinicians greater control during the biopsy.
Strategically, the clearance adds a high‑margin diagnostic device to BD’s MedTech portfolio and supports the company’s goal of expanding its connected‑care offerings. The system’s consumable‑driven model is expected to generate recurring revenue, reinforcing BD’s focus on high‑margin, repeat‑purchase products that complement its existing Alaris infusion and Pyxis medication delivery solutions.
BD’s recent financial performance underscores the importance of this new product line. In fiscal 2025, the company reported $5.9 billion in revenue for the fourth quarter, a 7% year‑over‑year increase, and an adjusted diluted EPS of $3.96. Full‑year 2025 revenue reached $21.8 billion, with an adjusted diluted EPS of $14.40, while $2.2 billion was returned to shareholders through dividends and share repurchases. The EnCor EnCompass™ clearance is expected to contribute to continued revenue growth and margin expansion in the MedTech segment.
Management highlighted the significance of the approval. Rima Alameddine, BD’s worldwide president of Peripheral Intervention, said the milestone “marks a meaningful advancement in breast health, playing a critical role in early detection and diagnosis.” Dr. Shadi Aminololama‑Shakeri, chief of breast radiology at UC Davis, noted that the system “combines multi‑modality capability and enhanced control into one platform that supports intraprocedural customization.” Stacie Watson, vice president and general manager of the Oncology Platform, added that the clearance “demonstrates our ongoing focus on addressing evolving needs of clinicians and patients in breast health.”
The clearance also aligns with BD’s broader investment strategy. The company recently announced a $110 million expansion of its prefillable syringe production in Columbus, Nebraska, to support biologic and GLP‑1 drug manufacturing, and named Shawn Bevec as senior vice president of investor relations. These moves reinforce BD’s commitment to high‑margin, consumable‑driven services and to expanding its footprint in both medical devices and pharmaceutical manufacturing.
In summary, the FDA clearance of the EnCor EnCompass™ Breast Biopsy System marks a milestone for BD’s MedTech strategy, expands its diagnostic portfolio, and supports the company’s objective of growing recurring revenue through connected‑care solutions.
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