SimBioSys has received its third FDA 510(k) clearance for TumorSight Viz 1.3, an AI platform that converts standard breast MRI scans into 3D visualizations for surgical planning. The latest clearance expands the platform’s capabilities with improved performance and workflow integration for breast cancer surgery.
TumorSight Viz 1.3 includes enhanced AI-driven segmentation for lesion identification and tumor volume estimation, producing results within minutes for same-day surgical planning. The platform adds PACS connectivity that automates image transfer and reduces manual tasks for physicians and staff.
“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.
Clinical validation studies have demonstrated the platform’s performance across more than 1,600 retrospective cases from over nine institutions. The technology addresses challenges in breast cancer surgery where re-excision rates remain above 20%, indicating opportunities for improved surgical planning.
“TumorSight Viz 1.3 helps eliminate guesswork in the OR,” said Dr. Barry Rosen, 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 supports surgical planning for margins, incisions, and reconstruction by converting complex MRI data into anatomy-specific visualizations. SimBioSys focuses on AI tools that enhance surgical clarity and enable individualized patient care in breast cancer treatment.
