SimBioSys announced that it received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons in the U.S.
Chicago-based SimBioSys picked up an initial FDA clearance for the platform at the start of this year. The updated TumorSight Viz now processes images with AI in a matter of minutes. It also integrates enhanced AI-driven tumor segmentation and enables seamless access to MRI images through direct connectivity to PACS systems.
The TumorSight platform takes a patient’s standard-of-care imaging to build a custom 3D model of their tumor. The tool provides 3D spatial visualizations of breast cancer to support more effective planning and consultations. Additionally, the TumorSight application provides insights like tumor volume, tumor-to-breast volume and tumor distance to key anatomical structures. It quantifies key metrics required in treatment planning.
SimBioSys designed the updated platform with a first-of-its-kind clinical decision support (CDS) feature. This informs providers of evidence-based treatment options. Adding the CDS application can enhance treatment planning and optimize decisions for early-stage breast cancer patients’ surgery.
TumorSight Viz gives healthcare providers a platform on which they can visualize MRI data in 3D to tailor treatment decisions. SimBioSys says this can help meet potential rising demand for MRI as a supplementary screening tool following a recent FDA mandate which now requires breast density reporting for all women undergoing a mammogram.
“This second FDA clearance represents a significant milestone in our mission to redefine precision medicine for cancer,” said Dr. Barry Rosen, chief medical officer at SimBioSys. “TumorSight Viz’s latest capabilities elevate the standard of breast cancer care by allowing surgeons to make more informed choices, moving closer to an era of precision surgery that reduces variation and supports breast conservation when desired by the patient.”
