BD Obtains FDA 510(ok) Clearance for the EnCor EnCompass System
BD (Becton, Dickinson and Firm) has obtained 510(ok) clearance from the U.S. Meals and Drug Administration (FDA) for the EnCor EnCompass Breast Biopsy and Tissue Elimination System.
The approval marks the introduction of a multimodality system designed to offer physicians with flexibility in breast imaging modalities for diagnosing breast situations.
Uncover B2B advertising and marketing that delivers
Mix enterprise intelligence and editorial excellence to achieve engaged professionals throughout 36 main media platforms.
Extra info
The system goals to streamline breast biopsy procedures by supporting use throughout a number of breast imaging platforms inside one built-in gadget. BD expects to carry the system to market in early 2026, highlighting options designed for procedural effectivity.
Key technical specs embody a variable pattern notch that may be adjusted throughout procedures, compatibility with completely different imaging platforms, excessive and low vacuum strengths, an echogenic chopping cannula for visualization, 360° sampling functionality, 10G, 7G and 12G probe choices for various lesion sorts, and an illuminated pattern container.
The FDA clearance broadens BD’s providing of breast well being applied sciences and helps BD’s continued efforts in early detection and prognosis.
BD Peripheral Intervention World President Rima Alameddine mentioned: “This milestone for our new breast biopsy system marks a significant development in breast well being and performs a crucial position in aiding the early detection and prognosis of breast illnesses.
“This innovation underscores our dedication to partnering with medical leaders to ship patient-centered options. Guided by our imaginative and prescient to remodel breast well being, we stay targeted on growing applied sciences that empower healthcare suppliers and encourage confidence in care.”
Vice President and Basic Supervisor of the BD Interventional-Peripheral Interventional Oncology Platform, Stacie Watson, mentioned, “The FDA approval of the EnCor EnCompass Biopsy System demonstrates our continued deal with addressing the evolving wants of physicians and sufferers in breast well being.
“This multimodal platform is designed to offer flexibility, management and ease of use, with options designed to assist each clinician confidence and the affected person expertise.”
In August 2025, BD introduced an funding of greater than $35 million to increase manufacturing capability for BD PosiFlush pre-filled flushing syringes at its Columbus, Nebraska, USA facility.
