iCAS-LV
HighRAD Ltd.The iCAS-LV software from HighRAD Ltd. is an advanced image analysis tool that helps physicians visualize and evaluate liver lesions in CT scans. It uses interactive segmentation, automatic registration, and volume measurement to track lesions' size, shape, and changes over time, supporting clinical decision-making without replacing physician judgment.
Intended Use
The iCAS-LV is intended to receive multi-phase volume datasets of reconstructed studies from PACS devices, to process them and to transfer the processing output to the PACS in DICOM format. It is a PC-based, self-contained, noninvasive image analysis software application. The device provides tools for visualization, measurements, segmentation, annotation, images registration, processing, and reporting. It supports physicians in visualization of CT reconstructed images and evaluation of physician-identified liver lesions, including size, shape, position and changes over time.
Technology
The iCAS-LV software workflow includes automated image registration, lesion segmentation using 3D U-Net deep learning models, interactive lesion labeling and correction by radiologists, semi-automatic lesion matching between scans, and quantitative analysis of lesion volume and diameter changes over time. It processes multi-phase CT volume datasets in DICOM format and outputs quantitative data to PACS systems.
Performance
Performance validation includes software verification and validation of unit, integration, and requirements testing, phantom testing with CT liver phantoms comparing algorithm volume and diameter estimates to expert radiologists, and clinical data analysis of 108 patients with 2,127 liver lesions showing strong agreement of iCAS volumetric assessment with radiologist ground truth. Testing covered multiple scanner vendors and international datasets.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/9/2023
8 months - 2
FDA Approval
3/1/2024
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