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

CHICAGO, July 9, 2025 /PRNewswire/ -- SimBioSys^®, a clinical AI company leveraging spatial biophysics to drive precision in breast cancer treatment, today announced its third FDA 510(k) clearance for TumorSight™ Viz. The clearance expands the platform's ability to convert standard breast MRI into intuitive, 3D visualizations that support more informed and individualized surgical decision-making. TumorSight Viz 1.3 builds on the platform's FDA-cleared foundation with new capabilities that significantly improve performance, expand clinical utility, and simplify integration into surgical workflows.

"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. TumorSight Viz 1.3 delivers a new level of intelligence and insight, helping surgeons see what's possible with greater confidence and enabling care that's truly aligned with each patient's unique anatomy and goals."

TumorSight™ Viz 1.3 marks the next evolution of a clinically validated platform, purpose-built to support greater consistency, precision, and efficiency in breast cancer surgery. With its third FDA clearance, TumorSight Viz delivers expanded functionality optimized for broader integration across surgical settings and supported by robust clinical validation. The latest release introduces:

• Superior AI-Driven Segmentation – Industry-leading accuracy in lesion segmentation and tumor volume estimation, enabling greater confidence in preoperative planning.¹
• Faster Case Processing – Produces results in minutes, enabling same-day insights that support more timely, informed conversations with patients.¹
• Streamlined Workflow Integration – New PACS connectivity automates image transfer and reduces manual tasks—enhancing efficiency for physicians and staff.¹

A growing body of evidence supports TumorSight Viz, 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—underscoring its readiness to support confident, anatomy-driven surgical care.^2,3

"TumorSight Viz 1.3 helps eliminate guesswork in the OR," said Barry Rosen, MD, FACS, Breast Surgical Oncologist, 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. It empowers us to make more informed decisions about margins, incisions, and reconstruction, and just as importantly, it helps patients visualize their care in a way that fosters trust, understanding, and confidence in the path forward."

Rising expectations around surgical precision and cosmetic outcomes are transforming breast cancer care. Re-excision rates remain above 20 percent, underscoring the need for technologies that support more accurate and confident surgical planning.⁴ 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.⁵ The National Comprehensive Cancer Network (NCCN) supports this shift with updated guidelines that emphasize evidence-based strategies for reconstruction and oncoplastic procedures.⁶ 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.

"With our third FDA clearance, growing clinical evidence, and alignment with modern standards of care, TumorSight Viz is setting a new benchmark for AI-powered surgical visualization in breast cancer," added Ms. Stevens. "We're proud to partner with clinicians who are driving progress in the OR every day—and remain committed to delivering solutions that enhance precision, enable shared decision-making, and ultimately support improved outcomes for patients nationwide."

About SimBioSys
SimBioSys is a clinical AI company leveraging spatial biophysics to drive precision in breast cancer treatment. By revolutionizing how cancer is understood and treated, SimBioSys is empowering clinicians with greater clarity, consistency, and confidence to deliver care aligned with each patient's unique needs. For more information, visit www.simbiosys.com.

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References:

1. SimBioSys data on file.
2. Weitz M, Pfeiffer JR, Patel S, Biancalana M, et al. (2024). Performance of an AI-powered visualization software platform for precision surgery in breast cancer patients. npj Breast Cancer. https://doi.org/10.1038/s41523-024-00696-6
3. Pekis A, Kannan V, Kaklamanos E, Antony A, Patel S, Earnest T. (2024). Seeing beyond cancer: Multi-institutional validation of object localization and 3D semantic segmentation using deep learning for breast MRI. In: Medical Imaging 2024: Image Processing (Vol. 12927, 129270H). SPIE. https://doi.org/10.1117/12.3009341
4. Morrow M, Abrahamse P, Hofer TP, Ward KC, Hamilton AS, Kurian AW, et al. (2017). Trends in reoperation after initial lumpectomy for breast cancer: Addressing overtreatment in surgical management. JAMA Oncology, 3(10), 1352-1357. https://jamanetwork.com/journals/jamaoncology/fullarticle/2630063
5.  Reid V, Gold LP, Brown EA, DiPasquale A, Peled G, Peterson JR, Rosen BS, et al. (2025). Breast surgery: Art or science? Survey of 36 experienced surgical and breast oncologists. Poster presented at the American Society of Breast Surgeons (ASBrS) Annual Meeting, Las Vegas, NV. Poster Number: 1983810.
6. National Comprehensive Cancer Network (NCCN). (2024). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2024. https://www.nccn.org/

SOURCE SimBioSys