BD Receives FDA 510(k) Clearance for EnCor EnCompass™ Breast Biopsy and Tissue Removal System

Rhea-AI Summary

BD (NYSE: BDX) received FDA 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System on January 15, 2026. The multi-modality biopsy system is designed to work across breast imaging platforms, offering adjustable vacuum strengths, a variable sample notch, 360° sampling, echogenic cutting cannula, illuminated sample container, and probe choices of 12G, 10G, and 7G. The system is expected to enter the market in early 2026, expanding BD's breast health portfolio to support earlier detection and diagnosis.

Positive

• FDA 510(k) clearance received on Jan 15, 2026
• Market entry planned for early 2026
• Designed for multi-modality use across imaging platforms
• 360° sampling capability for comprehensive lesion access
• Offers 12G, 10G, and 7G probe options

Negative

• None.

News Market Reaction

+0.45%

1 alert

+0.45% News Effect

On the day this news was published, BDX gained 0.45%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Planned market entry: Early 2026 Sampling capability: 360° sampling Probe size option: 12G probes +2 more

5 metrics

Planned market entry Early 2026 Expected commercial availability of EnCor EnCompass system

Sampling capability 360° sampling Access to lesions located throughout the breast

Probe size option 12G probes One of three probe gauges offered

Probe size option 10G probes One of three probe gauges offered

Probe size option 7G probes One of three probe gauges offered

Market Reality Check

Price: $175.89 Vol: Volume 1,394,069 is below...

normal vol

$175.89 Last Close

Volume Volume 1,394,069 is below 20-day average of 1,774,730 (relative volume 0.79x). normal

Technical Price 207.42 is trading above 200-day MA at 187.42, indicating a pre-news uptrend.

Peers on Argus

BDX was up 2.93% while key peers ALC (0.6%), RMD (2.31%), WST (0.75%), BAX (1.17...

BDX was up 2.93% while key peers ALC (0.6%), RMD (2.31%), WST (0.75%), BAX (1.17%) and HOLX (0.35%) also gained modestly, but no peers appeared in the momentum scanner, suggesting a more stock-specific move around BDX.

Historical Context

5 past events · Latest: Jan 13 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 13	Capacity investment	Positive	-0.6%	$110M Neopak syringe expansion and U.S. manufacturing investment plan.
Jan 12	Shareholder meeting	Neutral	-0.6%	Announcement of fully virtual 2026 annual shareholders meeting logistics.
Jan 05	Clinical milestone	Positive	+2.1%	First Phasix hernia prevention case in Greece and >85% PREVENT enrollment.
Dec 18	Research collaboration	Positive	-0.3%	Collaboration with Penn on 1,000-patient immune profiling via flow cytometry.
Dec 15	Product expansion	Positive	-1.9%	IVDR certification for new VIASURE assays on BD MAX system in Europe.

Pattern Detected

Recent history shows several positive strategic and clinical updates often met with flat to slightly negative next-day moves, with only one clear positive alignment.

Recent Company History

Over the last month, BD reported multiple developments across manufacturing, clinical programs and collaborations. A $110 million U.S. syringe investment and related $2.5 billion five-year manufacturing pledge preceded a -0.6% move. A virtual 2026 shareholder meeting also saw a -0.6% reaction. Clinical progress with Phasix™ and the PREVENT trial (> 85% enrolled, results targeted for 2026) aligned with a 2.06% gain. Collaborations in immunotherapy and IVDR-certified assays in Europe drew small negative reactions. Today’s FDA 510(k) clearance adds another product-focused milestone to this stream of updates.

Market Pulse Summary

This announcement highlights FDA 510(k) clearance for BD’s EnCor EnCompass breast biopsy and tissue ...

Analysis

This announcement highlights FDA 510(k) clearance for BD’s EnCor EnCompass breast biopsy and tissue removal system, with commercial entry targeted for early 2026. It adds to a series of recent product, clinical and collaboration milestones across BD’s portfolio. Investors may focus on how this multi-modality platform integrates into the existing breast health franchise, adoption across imaging modalities, and execution against previously disclosed manufacturing and clinical initiatives when assessing the longer-term impact.

Key Terms

510(k) clearance, multi-modality, breast biopsy, echogenic, +1 more

5 terms

510(k) clearance regulatory

"the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EnCor"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

multi-modality medical

"a state-of-the-art multi-modality breast biopsy system designed to provide clinicians"

Multi-modality describes products, tests, or technologies that use more than one type of input or method—such as combining images, lab measurements, and written reports in medicine, or merging text, audio, and visuals in software. For investors it matters because multi-modal approaches can address broader needs and create stronger competitive advantages, but they also often cost more to develop and face more complex testing and regulatory approval, similar to building a multi-tool instead of a single-use gadget.

breast biopsy medical

"state-of-the-art, multi-modality breast biopsy system slated to be in the market"

A breast biopsy is a medical procedure that removes a small sample of breast tissue so doctors can examine it under a microscope to determine whether an abnormality is benign or cancerous; think of it like taking a soil sample to test for contamination. Investors pay attention because biopsy rates, diagnostic accuracy, device approvals, reimbursement rules, and treatment decisions that follow results can affect demand for medical devices, imaging services, drug pipelines, and healthcare costs.

echogenic medical

"including an echogenic cutting cannula and illuminated sample container"

Echogenic describes tissue or a material that reflects ultrasound waves and therefore appears bright on an ultrasound image, much like a mirror shows up clearly when light hits it. For investors, echogenicity matters because it affects how well a device or product lets clinicians see what they need to see; higher echogenicity can improve diagnostic accuracy, reduce repeat tests, and strengthen a medical product’s competitive and regulatory position.

cannula medical

"including an echogenic cutting cannula and illuminated sample container"

A cannula is a small, hollow tube that medical staff insert into the body to deliver or remove fluids, medications, or gases—think of it like a medical straw or connector used for IV lines, oxygen therapy, dialysis, or surgical access. Investors track cannulas because regulation, manufacturing capacity, product quality and clinical adoption of these basic but widely used devices can affect sales, reimbursement and the broader performance of companies in medical supplies and devices.

AI-generated analysis. Not financial advice.

State-of-the-art, multi-modality breast biopsy system slated to be in the market in early 2026

FRANKLIN LAKES, N.J., Jan. 15, 2026 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System, a state-of-the-art multi-modality breast biopsy system designed to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease.

"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," said Rima Alameddine, worldwide president, Peripheral Intervention at BD. "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."

The EnCor EnCompass™ Biopsy System is designed to streamline the breast biopsy experience by enabling clinicians to perform procedures across a range of breast imaging platforms using one integrated system. The system, which is expected to enter the market in early 2026, offers a combination of advanced features and user-focused design to support procedural efficiency.

"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," said Stacie Watson, vice president and general manager of the Oncology Platform at BD Interventional–Peripheral Intervention. "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."

Key features of the EnCor EnCompass™ Biopsy System include:

• Multi-modality use to support procedures performed across breast imaging platforms
• High and low vacuum strengths and a variable sample notch that can be adjusted during the procedure
• 360° sampling capability to access lesions located throughout the breast
• Features to enhance visualization, including an echogenic cutting cannula and illuminated sample container
• Choice of 12G, 10G, and 7G probes to accommodate different lesion types and locations

"Our goal is always to provide the best possible care for patients while maintaining efficiency, accuracy, and safety," said Dr. Shadi Aminololama-Shakeri, M.D., Chief of Breast Radiology at UC Davis. "The EnCor EnCompass™ Biopsy System combines multi-modality capability and enhanced control into one platform that supports intraprocedural customization and helps streamline the biopsy process."

The clearance of the EnCor EnCompass™ Biopsy System expands BD's breast health portfolio and reflects the Company's ongoing commitment to advancing technologies that support early detection and diagnosis.

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiency, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) at @BDandCo or Instagram at @becton_dickinson.

Contacts:
Media:	Investors:
Fallon McLoughlin	Adam Reiffe
Director, Public Relations	Vice President, Investor Relations
201.258.0361	201.847.6927
fallon.mcloughlin@bd.com	adam.reiffe@bd.com

Indications for Use: The EnCor EnCompass™ Breast Biopsy and Tissue Removal System is indicated to acquire breast tissue for histologic examination with partial or complete removal of the abnormality. 
Contraindications: 1.) This device is not intended for use except as indicated. 2.) The EnCor EnCompass™ Breast Biopsy and Tissue Removal System is contraindicated for those patients where, in the physician's judgment, there is an increased risk of complications associated with percutaneous removal of tissue samples. 
Warnings: Attention: Histologic findings require correlation with imaging and clinical findings to determine concordance. If there is discordance between imaging, clinical findings, and/or pathology, further histological evaluation and potential, additional diagnostic or excisional procedures are still needed. Whenever breast tissue is removed, histological evaluation of the tissue should be performed per standard of care. Clinical and imaging surveillance should be conducted in accordance with established clinical practice guidelines and institutional protocols.
Potential Complications: Potential complications include, but are not limited to, hematoma, hemorrhage, hemothorax, pneumothorax, surgical intervention, infection, adjacent tissue injury, pain, allergic reaction, and tissue adherence to the biopsy probe during removal from the breast.

For more information, please consult the product labels and inserts for any indication, contraindications, hazards, precautions 
and directions for use.

BD, the BD Logo, Advancing the world of health and EnCor EnCompass are trademarks of Becton, Dickinson and Company or its affiliates. © 2026 BD. All Rights Reserved. BD-165500

View original content to download multimedia:https://www.prnewswire.com/news-releases/bd-receives-fda-510k-clearance-for-encor-encompass-breast-biopsy-and-tissue-removal-system-302661681.html

SOURCE BD (Becton, Dickinson and Company)

FAQ

What did BD (BDX) announce on January 15, 2026 about breast biopsy devices?

BD announced FDA 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System.

When will the EnCor EnCompass™ system from BD (BDX) be available to clinicians?

The company expects the EnCor EnCompass™ system to enter the market in early 2026.

What imaging platforms does the EnCor EnCompass™ system support for BD (BDX)?

The system is designed for multi-modality use, supporting procedures across a range of breast imaging platforms.

What key features did BD highlight for the EnCor EnCompass™ system (BDX)?

Highlighted features include adjustable high/low vacuum, a variable sample notch, 360° sampling, echogenic cutting cannula, and illuminated sample container.

What probe sizes are available for BD's EnCor EnCompass™ system (BDX)?

The system offers probe choices of 12G, 10G, and 7G to accommodate different lesion types and locations.

How does the EnCor EnCompass™ clearance affect BD's breast health offerings (BDX)?

The 510(k) clearance expands BD's breast health portfolio by adding a multi-modality biopsy and tissue removal platform.