SimBioSys, a clinical AI company specializing in spatial biophysics for breast cancer treatment, announced its third FDA 510(k) clearance for TumorSight Viz 1.3, an artificial intelligence-powered platform that transforms standard breast MRI into intuitive 3D visualizations for surgical decision-making. The clearance expands the platform's capabilities to support more informed and individualized surgical planning in breast cancer care.
Enhanced AI Performance and Clinical Integration
TumorSight Viz 1.3 builds upon the platform's FDA-cleared foundation with significant improvements in performance and clinical utility. The latest version introduces superior AI-driven segmentation that delivers industry-leading accuracy in lesion segmentation and tumor volume estimation, enabling greater confidence in preoperative planning. The platform now produces results in minutes, facilitating same-day insights that support more timely, informed conversations with patients.
"TumorSight Viz 1.3 helps eliminate guesswork in the OR," said Barry Rosen, MD, FACS, Breast Surgical Oncologist and Chief Medical Officer of SimBioSys. "This latest version brings a new level of clarity and control to breast cancer surgery—delivering the anatomical insight and intuitive design surgeons have long needed."
The platform incorporates streamlined workflow integration through new PACS connectivity that automates image transfer and reduces manual tasks, enhancing efficiency for physicians and staff. The tool employs 3D spatial visualization and automatic segmentation to display tumor shape, size, morphology, and location, providing reliable volume calculations to influence pre-surgical decision-making.
Clinical Validation and Performance Data
A growing body of evidence supports TumorSight Viz's clinical utility, with studies demonstrating strong concordance with radiologist annotations, accurate delineation of tumor size relative to breast volume, and consistent performance across more than 1,600 retrospective cases from more than nine institutions. In a validation set including 98 patients and 100 surgical cases, study investigators noted that results support the "relevance of TumorSight Viz generated measurements compared to real-world surgical implementation."
Based on an internal survey, 70% of surgeons rated TumorSight Viz as valuable or very valuable overall, with enhanced value noted in specific cases including multi-focal and multi-centric tumors, ductal carcinoma in situ, larger tumors, and disease near the skin or nipple.
Addressing Critical Clinical Needs
The platform addresses significant challenges in breast cancer surgery, where re-excision rates remain above 20 percent, underscoring the need for technologies that support more accurate and confident surgical planning. Data presented at the 2025 American Society of Breast Surgeons (ASBrS) Annual Meeting revealed significant variability in surgical decisions—even among experienced providers—reinforcing the need for standardized, data-driven approaches.
"This latest clearance represents a pivotal step forward in our mission to bring greater precision and progress in the fight against breast cancer," said Stacey Stevens, President and CEO of SimBioSys. "As the leading cancer diagnosed in women worldwide, breast cancer presents a complex and urgent challenge—demanding tools that enhance surgical clarity and enable more individualized care."
The National Comprehensive Cancer Network (NCCN) supports this shift with updated guidelines that emphasize evidence-based strategies for reconstruction and oncoplastic procedures. TumorSight Viz helps close this gap by converting complex MRI data into clear, anatomy-specific insights, enabling surgeons to operate with greater consistency and personalization.
Technology and Implementation
The platform leverages individual patient standard-of-care medical imaging and diagnostic data as inputs. Using trained AI, the tool automatically identifies tumor tissue to create a 3D model of the tumor and surrounding tissue, determining breast and tumor volume as well as distances to nearby anatomical features. Tumor-to-landmark assessments assist with planning optimal surgical outcomes during breast-conserving procedures.
TumorSight Viz helps clinicians decide between different breast-conserving surgery or mastectomy options by providing reliable volume calculations and anatomical insights. The platform empowers surgeons to make more informed decisions about margins, incisions, and reconstruction while helping patients visualize their care in a way that fosters trust, understanding, and confidence in the treatment path forward.
