CHICAGO--(BUSINESS WIRE)--SimBioSys, a pioneering TechBio company unlocking the power of spatial biophysics with artificial intelligence (AI) and biophysical modeling to redefine precision medicine for cancer, announced today it has received its first U.S. Food and Drug Administration (FDA) 510(k) clearance to market its first software application on its cloud-based digital precision medicine platform, TumorSight™.

“This is a landmark moment for the SimBioSys team and our many collaborators. It is our springboard to begin fulfilling our mission to redefine precision medicine as we launch this first application and target further expansion in clinical utilities within breast cancer as well as across other solid tumors,” says Tushar Pandey, co-founder and CEO of SimBioSys.

This is the company’s first FDA 510(k)-cleared device from its exciting pipeline of products. TumorSight™ Viz utilizes standard-of-care medical imaging (DCE MRI) to generate stunning 3D spatial visualization and key insights, giving clinicians and their patients a more comprehensive understanding of their cancer and the potential options available to them. The technology utilizes AI to automatically segment the tumor and surrounding tissue to display the 3D visualization. Further, this TumorSight™ software application provides key insights such as tumor volume, tumor-to-breast volume, and tumor distance to key anatomical structures in the breast to quantify key metrics required in treatment planning.
Breast cancer is the most common cancer diagnosis among women in the United States, representing 30% of all newly diagnosed cancers each year. Unfortunately, clinicians are severely lacking tools, especially tools that fit in their clinical workflow, to support them in working with their patients to ensure they get the optimal personalized treatment for their situation. Recently at the 2023 San Antonio Breast Cancer Symposium, SimBioSys shared the positive impact that visualization capabilities could have for clinicians and their consultations with patients:

70% of clinicians surveyed indicated that the tool was very valuable or valuable in their treatment planning.
66% of clinicians said it was critical or valuable in their consultation with their patient.
90% of breast cancer patient opinion leaders (POLs) interviewed saw the tool as very important for clinicians shared decision making with their patients.
80% of POLs believed it would increase patient confidence in their surgical decisions and in their surgeons.

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