With FDA approval secured, VizMark will begin commercial rollout of VM1 in the U.S., supported by clinician education initiatives for radiologists and breast surgeons
VizMark Secures FDA Approval for VM1 Visual Tumor Marker
December 22, 2025
VizMark Secures FDA Approval for VM1 Visual Tumor Marker, Advancing Precision in Breast Cancer Imaging
Plymouth, Minn. 12/22/2025 VizMark has received U.S. Food and Drug Administration (FDA) approval 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 approval 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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About VizMark
Our team, led by radiologist and women’s health advocate Dr. Michael T. Nelson, created VM-1 improve imaging under MRI necessary for high risk patients. Through years of research and collaboration, we’ve designed a marker that eliminates the challenges of traditional solutions, offering better outcomes for patients and providers alike.
Dr. Michael Nelson
Founder and primary inventor, Dr. Nelson is a Board-Certified Radiologist, former U.S. Navy Flight Surgeon, and Professor of Radiology at the University of Minnesota. A leader in Mammography, Interventional Radiology, and Women’s Health, he co-founded the Jane Brattain Breast Center at Park Nicollet Medical Center.
Dr. Michael Nelson
Founder, Chief Medical Officer, and radiology expert
Kim Nelson
Accomplished senior executive and board member with 30+ years in high-tech, leading business growth, revenue expansion, and successful exits, including roles at Oracle and Primus Knowledge (IPO).
Kim Nelson
CEO with a proven track record of driving innovation
Tom Murphy
With 30+ years in medical device sales, operations, and management, Mr. Murphy has deep expertise in the tumor marker space, leading operations and sales at Mermaid Medical, Argon Medical, and Angiotech.
Tom Murphy
VP of Operations, tumor marker specialist
Steve Karel
A biotech senior executive with startup experience, Mr. Karel has held roles as CEO, CFO, and SVP of Business Development. He brings expertise in finance, fundraising, corporate development, and R&D, strengthening VizMark’s operations and growth.
Steve Karel
CFO with deep expertise in medical finance
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