SimBioSys’ latest FDA 510(k) clearance for TumorSight™ Viz 1.3 marks a significant advancement in the integration of artificial intelligence and spatial biophysics into breast cancer surgery. As the third regulatory approval for the TumorSight platform, this version enhances its ability to transform standard breast MRI scans into intuitive, 3D anatomical visualizations, enabling clinicians to make more precise and personalized surgical decisions. The innovation lies in its superior AI-driven segmentation and real-time tumor volume estimation, which allow for clearer preoperative planning and a better understanding of each patient’s unique anatomical landscape.

The platform’s expanded functionality brings major advantages to surgical teams and patients alike. By reducing manual image-processing tasks through PACS connectivity, TumorSight Viz 1.3 streamlines workflows and delivers same-day results—facilitating more timely treatment discussions. The ability to visually map tumors in 3D improves accuracy in defining surgical margins, planning incisions, and optimizing cosmetic outcomes, which is increasingly important in today’s value-based care environment. Backed by validation across more than 1,600 cases from diverse institutions, the platform demonstrates high concordance with radiologist annotations and consistent performance across clinical settings.