EnterpriseWorks Startup SimBioSys Receives FDA Clearance

EnterpriseWorks startup SimBioSys received a milestone FDA clearance for its foundational digital precision medicine technology, TumorSight™, enabling expansion to future cutting-edge applications.

SimBioSys is unlocking the power of spatial biophysics with artificial intelligence (AI) and biophysical modeling to redefine precision medicine for cancer.

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.

This is the company’s first FDA 510(k)-cleared device from its pipeline of products.

“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.

Receiving FDA clearance is an exciting milestone as it paves the way to begin to delivering personalized and holistic support to clinicians and patients on the cancer care journey, redefining precision medicine and revolutionizing patient care.

The company was founded in 2018 by researchers at the University of Illinois Urbana-Champaign to explore the intersection between AI and biophysical simulations in oncology.