SimBioSys Granted FDA Clearance for First-of-Its-Kind TumorSight™, Advancing Digital Precision Medicine
SimBioSys, an innovative TechBio company that harnesses the potential of spatial biophysics through artificial intelligence (AI) and biophysical modeling to redefine precision medicine for cancer, has recently announced the attainment of its initial clearance from the U.S. Food and Drug Administration (FDA) under the 510(k) pathway. This clearance enables the company to market its inaugural software application on its cloud-based digital precision medicine platform, TumorSight™.
TumorSight™ Viz, the cleared software, utilizes standard-of-care medical imaging (DCE MRI) to produce compelling 3D spatial visualizations and crucial insights, offering clinicians and their patients a more comprehensive understanding of cancer and potential treatment options. The application employs AI for automatic tumor and tissue segmentation, facilitating the creation of 3D visualizations.
Furthermore, TumorSight™ provides key metrics, such as tumor volume, tumor-to-breast volume ratio, and tumor distance to essential anatomical structures in the breast, aiding in treatment planning. Given that breast cancer accounts for 30% of all newly diagnosed cancers among women in the United States, TumorSight™ Viz aims to fill the gap in clinicians' tools by seamlessly integrating 3D spatial visualizations into their workflow to support personalized treatment decisions.