FDA Clears AI-Based Visualization Software for Surgical Breast Cancer Care

Developers designed TumorSight Viz to employ 3D spatial visualization and automatic segmentation to display tumor shape, size, morphology, and location.

The FDA has granted 510(k) clearance to TumorSight™ Viz, an artificial intelligence (AI)–based tool, to convert standard breast MRI into 3D visualizations in breast cancer surgery, according to a press release from the developer, SimBioSys®.1

Version 1.3 of TumorSight Viz expands upon the regulatory agency’s foundation by providing new capabilities that may improve its performance, expand its clinical utility, and simplify its implementation into surgical workflows. According to the developers, the latest version of the platform includes superior AI-driven segmentation that fuels greater confidence in preoperative planning. Additionally, the tool enables same-day results and insights that inspire timely, informed conversations with patients. It also makes use of picture archiving and communication system connectivity to automate image transfer and reduce manual tasks, thereby improving efficacy for staff and physicians.

“TumorSight Viz 1.3 helps eliminate guesswork in the [operating room]. 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,” Barry Rosen, MD, FACS, a breast surgical oncologist and chief medical officer at SimBioSys, stated in the press release.1 “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.”

Developers designed TumorSight Viz to employ 3D spatial visualization and automatic segmentation to display tumor shape, size, morphology, and location.2 Additionally, the platform may provide reliable volume calculations to influence pre-surgical decision-making, helping clinicians decide on employing different breast-conserving surgery or mastectomy options. Tumor-to-landmark assessments also assist with planning optimal surgical outcomes during breast-conserving procedures.

The platform makes use of individual patient standard-of-care medical imaging and diagnostic data as inputs. Leveraging trained AI, the tool then automatically identifies tumor tissue to create a 3D model of the tumor and surrounding tissue to determine breast and tumor volume as well as distances to nearby anatomical features.

Based on an internal survey, 70% of surgeons rated TumorSight Viz as valuable or very valuable overall. Survey responses noted enhanced value in specific cases like multi-focal and multi-centric tumors, ductal carcinoma in situ, larger tumors, and disease near the skin or nipple.

“This latest clearance represents a pivotal step forward in our mission to bring greater precision and progress in the fight against breast cancer. 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,” Stacey Stevens, president and chief executive officer of SimBioSys, stated.1 “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.”

The press release noted that studies assessing TumorSight Viz have demonstrated strong concordance with radiologist annotations, accurate delineation of tumor size relative to the breast, and consistent results in more than 1600 retrospective cases across more than 9 institutions. Findings exhibiting the software platform’s performance in precision surgery for patients with breast cancer were previously published in NPJ Breast Cancer.3

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.”3 The authors wrote that the platform would continue to undergo updates and expansions as development proceeds for additional indications and organ systems.

References

1. SimBioSys secures third FDA clearance for TumorSight™ Viz, advancing AI-powered precision surgery in breast cancer care. News release. SimBioSys. July 9, 2025. Accessed July 11, 2025. https://tinyurl.com/4bur9cwy
2. TumorSight Viz. SimBioSys. Accessed July 11, 2025. https://tinyurl.com/2scmdvfa
3. Weitz M, Pfeiffer JR, Patel S, et al. NPJ Breast Cancer. 2024;10(1):98. doi:10.1038/s41523-024-00696-6.