VizMark Secures FDA 510k Clearance for VM1 Visual Tumor Marker, Advancing Precision in Breast Cancer Imaging

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PLYMOUTH, Minn.--(BUSINESS WIRE)--Jan 14, 2026--

VizMark has received U.S. Food and Drug Administration FDA 510k clearance for VM1, a non-metal visual tumor marker designed to provide artifact-free visibility across all major breast imaging modalities, including MRI, mammography, X-ray, CT, and ultrasound.

VM1 was developed to address long-standing limitations of metallic markers, which can create artifacts on MRI and complicate imaging follow-up, particularly for patients undergoing multimodal or high-risk surveillance.

Constructed from biocompatible, non-metallic materials, VM1 is designed for long-term implantation and consistent visualization over time. VizMark said the marker supports accurate tumor localization without degrading image quality, an increasingly important consideration as MRI plays a larger role in breast cancer diagnosis, treatment planning, and surveillance—especially for patients with dense breast tissue.

“Reliable marker visibility without MRI artifact has been a persistent challenge in breast imaging,” said Dr. Michael T. Nelson, VizMark founder and Professor of Radiology at the University of Minnesota. “VM1 was engineered to integrate seamlessly into modern imaging workflows while prioritizing diagnostic confidence and patient safety.”

VM1 is optimized for risk-based breast cancer care models that rely on multimodal imaging throughout the patient journey, from biopsy through surgical planning and longitudinal follow-up.

With FDA 510k clearance secured, VizMark said it will begin commercial rollout of VM1 in the U.S., supported by clinician education initiatives for radiologists and breast surgeons. The company is also working with health systems and payers to support adoption under existing biopsy and localization reimbursement pathways.

VizMark is a medical technology company focused on developing imaging solutions for women’s health, with an emphasis on improving diagnostic accuracy and patient experience in breast cancer care.

For more information, visit www.vizmark.com.

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CONTACT: Kim Nelson

[email protected]

952.600.2934

KEYWORD: MINNESOTA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE RADIOLOGY RESEARCH ONCOLOGY HEALTH FDA CLINICAL TRIALS

SOURCE: VizMark

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PUB: 01/14/2026 01:02 PM/DISC: 01/14/2026 01:02 PM

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