{"id":62494,"date":"2026-01-14T19:06:27","date_gmt":"2026-01-14T18:06:27","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/vizmark-secures-fda-510k-clearance-for-vm1-visual-tumor-marker-advancing-precision-in-breast-cancer-imaging\/"},"modified":"2026-01-14T19:06:27","modified_gmt":"2026-01-14T18:06:27","slug":"vizmark-secures-fda-510k-clearance-for-vm1-visual-tumor-marker-advancing-precision-in-breast-cancer-imaging","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/vizmark-secures-fda-510k-clearance-for-vm1-visual-tumor-marker-advancing-precision-in-breast-cancer-imaging\/","title":{"rendered":"VizMark Secures FDA 510k Clearance for VM1 Visual Tumor Marker, Advancing Precision in Breast Cancer Imaging"},"content":{"rendered":"
\n

PLYMOUTH, Minn.–(BUSINESS WIRE)–VizMark has received U.S. Food and Drug Administration FDA 510k clearance for VM1<\/b>, 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.<\/p>\n

<\/a>
<\/a><\/p>\n

\nVM1 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.<\/p>\n

\nConstructed 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\u2014especially for patients with dense breast tissue.<\/p>\n

\n\u201cReliable marker visibility without MRI artifact has been a persistent challenge in breast imaging,\u201d said Dr. Michael T. Nelson<\/b>, VizMark founder and Professor of Radiology at the University of Minnesota. \u201cVM1 was engineered to integrate seamlessly into modern imaging workflows while prioritizing diagnostic confidence and patient safety.\u201d<\/p>\n

\nVM1 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.<\/p>\n

\nWith 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.<\/p>\n

\nVizMark is a medical technology company focused on developing imaging solutions for women\u2019s health, with an emphasis on improving diagnostic accuracy and patient experience in breast cancer care.<\/p>\n

\nFor more information, visit www.vizmark.com<\/b><\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nKim Nelson
\n
info@vizmark.com<\/a>
952.600.2934
\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

PLYMOUTH, Minn.–(BUSINESS WIRE)–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 … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62494","6":"format-standard","7":"category-industry"},"yoast_head":"\nVizMark Secures FDA 510k Clearance for VM1 Visual Tumor Marker, Advancing Precision in Breast Cancer Imaging - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/vizmark-secures-fda-510k-clearance-for-vm1-visual-tumor-marker-advancing-precision-in-breast-cancer-imaging\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"VizMark Secures FDA 510k Clearance for VM1 Visual Tumor Marker, Advancing Precision in Breast Cancer Imaging - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"PLYMOUTH, Minn.–(BUSINESS WIRE)–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. 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