TumorSight Viz
SimBioSys, Inc.TumorSight Viz is a cloud-based AI software that helps clinicians visualize and analyze breast MRI images in patients with early-stage or locally advanced breast cancer. It processes dynamic contrast-enhanced MRI data to provide 3D renderings, measurements, and segmentations of tumors, supporting more informed clinical evaluations and treatment planning.
Intended Use
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. It supports evaluation of dynamic MR data acquired during contrast administration and performs processing such as image registration, subtractions, measurements, 3D renderings, and reformats.
Technology
TumorSight Viz is a cloud-based proprietary software that reads and processes dynamic contrast-enhanced breast MRI DICOM images. It provides visualization features like standard image viewing, maximum intensity projections (MIPs), image registration, subtraction series, kinetic curves, parametric maps, automatic volume segmentation, and 3D volume rendering for evaluation and analysis.
Performance
Performance testing was conducted on 833 patient datasets for training and tuning, and 216 patients for validation across multiple U.S. clinical sites, ensuring demographic and clinical diversity. Validation showed TumorSight Viz's measurements of tumor volume and distances were comparable to expert radiologist measurements with clinically acceptable error margins. Tumor segmentation Dice scores averaged 0.75 volumetric and 0.88 surface indicating strong agreement with ground truth. Results demonstrated TumorSight Viz’s performance is substantially equivalent to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
25 days - 2
FDA Approval
10/25/2024
Other devices from SimBioSys, Inc.
- TumorSight Viz2025 • 510K
- TumorSight Viz2023 • 510K
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