Salix Central
Artrya LimitedSalix Central is a cloud-based software that helps cardiologists and radiologists analyze cardiac CT scans. It assists in identifying coronary plaques, stenosis, and performing calcium scoring, supporting clinical decision-making in assessing heart disease.
Intended Use
Salix Central is a web-based software application intended to be used for viewing, post-processing, and analyzing cardiac CT images in DICOM format, providing tools for qualitative and quantitative assessment of physician-identified coronary plaques and stenosis in coronary computed tomography angiography (CCTA) and calcium scoring in non-contrast cardiac CT.
Technology
Salix Central is a cloud-hosted, web-based software using machine learning-enabled algorithms trained on a large multi-site dataset. It enables physician-driven coronary analysis including calcium scoring, centerline extraction, vessel labeling, and lumen and vessel wall segmentation. The software is accessed via a SaaS model on AWS cloud services.
Performance
Performance validation tested ML outputs (calcium scoring, centerline extraction, vessel labeling, lumen and vessel wall segmentation) against ground truth annotated by certified cardiologists and radiologists on a dataset of 363 de-identified cardiac CT studies from multiple US centers and device manufacturers. The device exceeded pre-defined acceptance criteria for all tests, demonstrating accuracy and reliability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
6 months - 2
FDA Approval
3/27/2025
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