VizMark Secures FDA Clearance for Visual Tumor Marker
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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.
