SimBioSys Achieves Second FDA Clearance for TumorSight™ Viz and Introduces TumorSight™ Clinical Decision Support for Breast Cancer Surgery

CHICAGO, Nov. 4, 2024 /PRNewswire/ -- SimBioSys®, a pioneering TechBio company at the forefront of digital precision medicine for cancer care, is proud to announce its second FDA 510(k) clearance for TumorSight™ Viz to expand its use by breast surgeons across the US. The updated TumorSight Viz now processes images with AI in a matter of minutes, integrates enhanced AI-driven tumor segmentation, enables seamless access to MRI images through direct connectivity to PACS systems, and has a first of its kind clinical decision support (CDS) feature that informs providers of evidence-based treatment options.  The addition of the CDS application is designed to enhance treatment planning and optimize oncologists' decisions for early-stage breast cancer patients' surgery.

With the recent FDA mandate which now requires breast density reporting for all women undergoing a mammogram, the demand for MRI as a supplementary screening tool is anticipated to rise. TumorSight Viz offers healthcare providers a powerful platform to visualize MRI data in 3D, supporting breast surgeons in tailoring treatment decisions to each patient's unique tumor characteristics. The platform's new CDS tool is designed to empower providers with advanced imaging insights and best practices for breast-conserving surgeries, aligning with updated NCCN guidelines promoting minimally invasive approaches when feasible and desired by patients.

"TumorSight Viz's clinical decision support functionality provides a groundbreaking resource to assist breast surgeons and oncologists in considering the best possible approaches for each patient, fostering shared decision-making and precision care," said Dr. Freya Schnabel from NYU.

TumorSight Viz: Key Enhancements

• Enhanced AI-Driven Segmentation: Utilizing AI, TumorSight Viz is designed to deliver accurate and efficient tumor and tissue segmentation, enabling detailed 3D spatial visualization to support treatment planning.
• Clinical Decision Support (CDS) Application: The new CDS application is designed to provide data-driven insights for informing breast surgeons' planning and preparation for surgery
• Direct MRI Access via PACS Systems: TumorSight Viz now supports integration with middleware software as well as direct to PACS systems, allowing automated access to MRI images for analysis within the TumorSight platform and seamless fit into the clinician workflow.

Recent NCCN guideline updates emphasize the importance of individualized, data-supported treatment planning to support breast reconstruction and oncoplastic surgery as safe and effective options for eligible patients. TumorSight Viz aligns with these recommendations by enabling volume and anatomical measurements that assist surgeons in utilizing volume displacement techniques with a goal to achieve optimal cosmetic and functional outcomes. With the new CDS capability, surgeons are now better equipped with output measurements from TumorSight Viz that are aligned with standard of care guidelines to help plan lumpectomies more precisely, supporting both effective tumor removal and preservation of breast appearance.

A Game-Changer in Breast Cancer Care

Breast cancer affects more than 300,000 patients in the U.S. annually, many of whom now stand to benefit from SimBioSys's enhanced TumorSight platform. By combining advanced AI-driven visualizations with CDS tools, TumorSight Viz is designed to provide surgeons, together with their patients, greater confidence in their treatment decisions.

"This second FDA clearance represents a significant milestone in our mission to redefine precision medicine for cancer," said Barry Rosen, MD, 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."

TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer.

About TumorSight™ Viz:
TumorSight™ Viz provides clinicians with 3D spatial visualizations of breast cancer using standard-of-care medical imaging (DCE MRI). Clear 3D "digital twin" renderings automatically display the tumor in the context of auto-segmented anatomical structures and provide key metrics used to inform the treatment planning process in conjunction with patient history and standard of care testing. TumorSight™ Viz received its original 510(k) FDA clearance in December 2023. Learn more about TumorSight Viz at https://simbiosys.com/tumorsight-viz.

About SimBioSys:
SimBioSys is a pioneering TechBio company leveraging artificial intelligence and computational modeling to harness the power of spatial biophysics to redefine precision medicine, transform patient care, and defeat cancer. By seeing cancer more completely, SimBioSys aims to empower clinicians and researchers with a more informed understanding of a patient's tumor to optimally assess all available options and deliver on the promise of truly individualized patient care. To learn more, visit us at https://www.simbiosys.com/.

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SOURCE SimBioSys