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Home » BD wins FDA nod for breast biopsy, tissue removal system

BD wins FDA nod for breast biopsy, tissue removal system

January 15, 2026 By Sean Whooley

BD EnCor EnCompass breast biopsy and tissue removal system (1)
The EnCor EnCompass breast biopsy and tissue removal system. [Image courtesy of BD]
BD (NYSE: BDX) announced today that the FDA granted 510(k) clearance for its EnCore EnCompass breast biopsy and tissue removal system.

The company described EnCor EnCompass as a state-of-the-art, multi-modality breast biopsy system. BD designed the system to deliver flexibility for clinicians across breast imaging modalities in the diagnosis of breast disease.

BD said the biopsy system can help streamline the breast biopsy experience. It gives clinicians a way to perform procedures across a range of breast imaging platforms through one integrated system. EnCor EnCompass offers a combination of advanced features and a user-focused design to support procedural efficiency, according to a news release.

Key features include high and low vacuum strengths and a variable sample notch that clinicians can adjust during the procedure. It has 360° sampling capabilities to access lesions located throughout the breast, plus enhanced visualization. BD said the system has an echogenic cutting cannula and an illuminated sample container. Clinicians can choose between 12G, 10G and 7G probes to accommodate different lesion types and locations.

BD said the clearance of EnCor EnCompass expands its breast health portfolio and reflects its commitment to early detection and diagnosis.

The company expects to launch the system this year.

Commentary from BD officials

Rima Alameddine, worldwide president, Peripheral Intervention at BD, said:

“This milestone for our new breast biopsy system marks a meaningful advancement in breast health, playing a critical role in aiding the early detection and diagnosis of breast disease. This innovation underscores our commitment to partnering with clinical leaders to deliver patient-centered solutions. Guided by our vision to transform breast health, we remain focused on developing technologies that empower providers and inspire confidence in care.”

Stacie Watson, VP and GM of the Oncology Platform at BD Interventional–Peripheral Intervention, said:

“The FDA clearance of the EnCor EnCompass biopsy system demonstrates our ongoing focus on addressing the evolving needs of clinicians and patients in breast health. This multi-modality platform is engineered to provide flexibility, control, and ease of use, with features designed to support both clinician confidence and the patient experience.”

Filed Under: 510(k), Diagnostics, Food & Drug Administration (FDA), Mammography, Oncology, Regulatory/Compliance, Women's Health Tagged With: BD, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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