TumorSight Viz
SimBioSys, Inc.TumorSight Viz is software developed by SimBioSys, Inc. that helps doctors visualize and analyze breast MRI images from patients with early-stage or locally advanced breast cancer. It supports dynamic MRI data evaluation by processing images to provide measurements, 3D renderings, and visualizations, which aid clinicians in planning treatment and assessing tumor characteristics. The system is cloud-based and used as a tool to support but not replace clinical decision-making.
Intended Use
Used in visualization and analysis of breast MRI studies for patients with biopsy proven early-stage or locally advanced breast cancer. Supports evaluation of dynamic MR data acquired during contrast administration. Performs image registration, subtractions, measurements, 3D renderings, and reformats. Includes user-configurable features for visualization and analysis of findings in breast MRI studies.
Technology
TumorSight Viz is a cloud-hosted proprietary software that reads DICOM MR images and provides visualization and analysis tools including standard image viewing, maximum intensity projections (MIPs), reformats, image registration, kinetic curves, parametric maps, automatic volume segmentation using deep learning, and linear measurements. Results are accessed through a web application.
Performance
Performance was validated using an independent dataset of 163 breast cancer patient MRI studies with pathologically confirmed disease from 6 clinical sites. The system's tumor volume and landmark distance measurements were comparable to expert radiologist measurements with variability similar to inter-radiologist variability. Tumor segmentation achieved mean volume Dice coefficient of 0.676 and surface Dice coefficient of 0.873, meeting acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/20/2023
8 months - 2
FDA Approval
12/26/2023
Other devices from SimBioSys, Inc.
- TumorSight Viz2025 • 510K
- TumorSight Viz2024 • 510K
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