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SimBioSys Secures Third FDA Clearance for TumorSight™ Viz, Advancing AI-Powered Precision Surgery in Breast Cancer Care

UNITED STATES, JUL 10 – TumorSight Viz reduces breast cancer surgery re-excision rates above 20% by providing AI-driven 3D MRI visualizations for improved surgical precision, clinical data shows.

  • On July 9, 2025, in Chicago, SimBioSys announced that its TumorSight Viz platform received a third regulatory clearance from the FDA, introducing version 1.3 with advanced AI features that improve surgical planning for breast cancer.
  • This clearance follows clinical evidence showing wide variability in surgical decisions and rising needs for standardized, precision-guided breast cancer surgery.
  • TumorSight Viz 1.3 transforms conventional breast MRI scans into detailed three-dimensional models, enhancing accuracy, ease of use, and seamless integration within surgical workflows to aid personalized surgical planning.
  • Barry Rosen, MD, stated that TumorSight Viz 1.3 enhances surgeons' ability to clearly understand anatomical details during breast cancer surgery, enabling more precise decision-making.
  • The clearance strengthens SimBioSys’s commitment to improving patient outcomes by enabling more precise, consistent, and confident breast cancer surgery aligned with modern care standards.
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SimBioSys Secures Third FDA Clearance for TumorSight™ Viz, Advancing AI-Powered Precision Surgery in Breast Cancer Care

Latest release introduces industry-leading AI performance, optimized workflow integration, and enhanced surgeon usability to streamline imaging-to-intervention planning

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PR Newswire broke the news in United States on Wednesday, July 9, 2025.
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