FDA Clears AI-Based Visualization Software for Surgical Breast Cancer Care
July 12, 2025
The FDA has granted 510(k) clearance to TumorSight™ Viz, an AI-driven software developed by SimBioSys® that transforms standard breast MRI images into detailed 3D visualizations to aid breast cancer surgery. The latest Version 1.3 introduces enhanced features aimed at improving surgical planning, clinical utility, and integration into existing workflows.
Enhanced Precision and Efficiency in Surgery
TumorSight Viz uses advanced AI segmentation to provide clearer, more accurate views of tumor shape, size, and location. This enables surgeons to plan procedures with greater confidence, potentially improving outcomes by helping to determine optimal margins and surgical approaches.
The software supports same-day results, facilitating prompt, informed discussions with patients. It also integrates with picture archiving and communication systems (PACS) to automate image transfer, reducing manual workload for healthcare teams.
Features Supporting Surgical Decision-Making
- 3D spatial visualization of tumor and surrounding tissues
- Automatic segmentation for tumor identification and volume calculation
- Assessment of tumor-to-landmark distances to guide breast-conserving surgery
- Utilization of individual patient imaging and diagnostic data to tailor surgical plans
These features assist clinicians in deciding between breast-conserving surgery and mastectomy, particularly in complex cases like multi-focal or multi-centric tumors, ductal carcinoma in situ, or tumors near the skin or nipple.
Positive Surgeon Feedback and Clinical Validation
An internal survey found that 70% of surgeons rated TumorSight Viz as valuable or very valuable overall. The software’s accuracy and consistency have been demonstrated in over 1,600 retrospective cases across nine institutions, showing strong agreement with radiologist assessments.
Published findings in NPJ Breast Cancer confirm the platform’s precision in surgical planning. In a validation study including 98 patients and 100 surgical cases, TumorSight Viz measurements closely aligned with real-world surgical outcomes, supporting its clinical relevance.
Looking Ahead
SimBioSys emphasizes ongoing development of TumorSight Viz to expand its applications to other organ systems and indications. The goal is to provide surgeons with reliable, AI-enhanced visualization tools that improve surgical clarity and patient care.
Barry Rosen, MD, FACS, chief medical officer at SimBioSys, highlighted that the software helps eliminate guesswork during surgery and fosters better patient understanding by visualizing their treatment clearly.
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