TRAQinform IQ
AIQ Global, Inc.TRAQinform IQ is a cloud-based software tool designed to aid medical professionals by providing quantitative analysis of lesions identified in PET/CT scans. It uses AI techniques such as machine learning for anatomical and skeletal segmentation and automates matching and quantitative assessment of regions of interest between multiple scans. The device generates detailed reports on lesion volume and tracer uptake changes over time, supporting clinicians in oncology and nuclear medicine to monitor disease progression and treatment response.
Intended Use
TRAQinform IQ is a software-only device that provides quantitative analysis of lesions identified as Regions of Interest (ROI) in PET/CT DICOM compliant imaging data acquired, interpreted, and reported on per local practice prior to device use. It performs automated matching of ROIs between images, uses machine learning skeletal and anatomical segmentation, threshold-based ROI contouring, and quantitative analysis including tracer uptake changes for FDG and PET targeted drugs. It outputs a detailed quantitative TRAQinform Report for use by trained medical professionals.
Technology
The software uses automated threshold-based ROI segmentation with options for importing physician established contours, performs multi-image ROI registration and matching (including multi-modality and multi-tracer PET), and quantitative analysis of changes in ROI shape, volume, density, and tracer uptake metrics. It relies on machine learning algorithms for skeletal and anatomical segmentation. It operates in a secure cloud environment with web browser access.
Performance
Performance testing included software verification and validation for CT segmentation, PET thresholding, ROI matching, test-retest reproducibility evaluation in a non-small cell lung cancer cohort, and a pivotal clinical utility study. The pivotal study evaluated 103 patients with two sequential FDG PET/CT scans, comparing TRAQinform IQ adjunctive reports to local reads and a radiology/oncology panel for reference, demonstrating good agreement on ROI classification and patient progression evaluation. The device is found substantially equivalent to the predicate based on similar intended use, technology, and clinical validation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/18/2023
8 months - 2
FDA Approval
9/5/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.