FDA Clears Multimodality Tumor Marker for Breast Cancer Imaging

The Food and Drug Administration (FDA) has granted 510(k) clearance for the emerging non-metallic tumor marker VM1, which can be utilized to enhance detection and long-term surveillance for mammography, breast ultrasound and breast MRI exams.

Designed for long-term implantation, the VM1 tumor marker enhances tumor localization with no sacrifice of image quality over time, key considerations in imaging for patients at high risk for breast cancer and recurrence of the disease, according to VizMark, the developer of the VM1 tumor marker.

While MRI artifacts and complications with follow-up imaging have been long-standing issues with the use of metallic markers, VizMark said the VM1 tumor marker is made of biocompatible, non-metallic materials, facilitating accurate visualization for patients undergoing surveillance imaging.

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