SimBioSys Earns 3rd FDA OK for TumorSight Viz AI Breast Cancer Tool

SimBioSys, a clinical artificial intelligence (AI) company using spatial biophysics in breast cancer treatment, has earned its third U.S. Food and Drug Administration (FDA) 510(k) clearance for TumorSight Viz, a cloud-based digital medicine platform.

TumorSight Viz, first FDA-cleared in January 2024, uses standard-of-care medical imaging (DCE MRI) to create 3D spatial visualization and key insights to give a more comprehensive understanding of the specific cancer and the options available to treat it. The newly cleared TumorSight Viz 1.3 software augments the tool’s ability to convert standard breast MRI into 3D visualization to support surgical decision-making.

The latest release features improved accuracy in lesion segmentation and tumor volume estimation. It produces results in minutes for same-day day insights to support timely, informed conversations with patients. New PACS connectivity automates transfer of images and reduces manual tasks, according to the company.

Barry Rosen, MD, FACS, a breast surgical oncologist and SimBioSys’ chief medical officer, said TumorSight Viz 1.3 helps to remove 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,” Dr. Rosen told the press. “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.”

SimBioSys said the technology is supported by over 1,600 retrospective cases that show strong concordance with radiologist annotations, accurate delineation of tumor size relative to breast volume, and consistent performance. Further, it addresses the rising expectations of surgical precision and cosmetic outcomes in breast cancer care—the tool converts complex MRI data into clear, anatomy-specific insights to help surgeons operate with better consistency and personalization.

SimBioSys president and CEO Stacey Stevens said this latest FDA clearance is a pivotal step toward the company’s mission to offer 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,” Stevens said. “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.”

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