iCAS-LV

by HighRAD  · Based in Israel →Revolutionizing oncology care by advancing the understanding of disease progression through longitudinal, multi-organ analysis.
Nuclear Medicine Oncology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The intelligent Computer Assessment Support (iCAS-LV™) is a computer-based Quantitative Changes Analysis of Lesion Volumetric Changes for radiological follow-up of longitudinal liver contrast-enhanced CT (ceCT) volumetric scans. HighRAD’s AI imaging platform is designed to track the entire patient journey, offering profound insights into disease progression through advanced quantitative, multi-organ analysis. It provides quantitative imaging analysis, automated lesion measurement, workflow integration, and standardized reporting, enabling radiologists, oncologists, and pharmaceutical research teams to gain deeper disease insight, make more confident clinical decisions, and improve treatment planning. The technology enhances disease understanding and significantly improves treatment outcomes, boosting radiologist productivity, and enabling quicker, more confident diagnoses.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-generated lesion detection for up to 3x faster oncology reporting
  • Accurate volumetric measurement of known and unknown lesions
  • Longitudinal comparison of findings (through all available studies)
  • Automated report generation for streamlined RECIST 1.1 documentation
  • Multi-organ view for complete standardized reporting
  • Seamless connectivity, integrating with all CT, MRI, and PET systems
  • AI-Powered Longitudinal Quantitative Analysis using Simultaneous Deep Learning technology (SimU-Net)
  • Automatic Lesion Detection & Segmentation
  • Data Processing and Integration

Use Cases

  • Tracking oncology patient journey
  • Radiological follow-up of longitudinal liver contrast-enhanced CT (ceCT) volumetric scans
  • Evaluating disease progression and treatment efficacy
  • Streamlining data retrieval and analysis for faster reporting
  • Supporting personalized treatment planning
  • Pharmaceutical tool for evaluating treatment or drug responses and tracking clinical studies

What Physicians Need to Know

Key Capabilities
iCAS-LV offers tools for visualization, interactive segmentation of radiologist-identified liver lesions, automatic lesion length (diameter) and volume computation, and supervised automatic liver registration for prior and current contrast-enhanced CT (ceCT) scans. It also provides semi-automatic lesion matching and automatic lesion length/volume change over time computation. The system includes AI-generated lesion detection for up to 3x faster oncology reporting, accurate volumetric measurement of known and unknown lesions, longitudinal comparison of findings, and automated RECIST 1.1 documentation with a multi-organ view.
Clinical Utility
The device supports physicians in visualizing CT reconstructed images and evaluating physician-identified liver lesions, aiding in the assessment of lesion size, shape, position, and changes over time. It is intended to empower oncology reporting by streamlining data retrieval and analysis, providing greater clinical depth. Importantly, iCAS-LV should not be used in isolation for diagnosis and patient management decisions.
Integration Options
iCAS-LV is designed to receive multi-phase volume datasets from Picture Archiving and Communication Systems (PACS) devices and transfer its processing output back to PACS in DICOM format, ensuring compatibility with existing radiology workflows. It operates as a PC-based, self-contained software application.
Compliance Status
The iCAS-LV has received FDA 510(k) clearance (K231690) and is classified as a Class II medical device under the product code QIH (Medical image management and processing system). It was designed, verified, and validated in compliance with 21 CFR, Part 820.30 requirements and EN ISO 14971:2019 for risk management.
User Experience
The software features a graphical user interface that allows trained physicians to interact with the system, visualize CT data, select tools, and manage the workflow efficiently.
Implementation Complexity
As a PC-based, self-contained software application, iCAS-LV underwent comprehensive software verification and validation, with demonstrated passing results across unit, integration, and requirements testing.
Evidence Base
The effectiveness of iCAS-LV is supported by software verification and validation, including a phantom study that evaluated sphere volume and difference, showing strong performance against ground truth and expert radiologists. A clinical data analysis comparing physician-assisted iCAS software estimates to ground truth from three radiologists further supported its utility based on DICE, ASSD, SHD, volume, and RECIST measurements. The deep learning algorithm was validated using a retrospective multi-site dataset comprising 108 patients with 219 ceCT scans and 2,127 liver lesions.
Physician Tip

iCAS-LV is a powerful assistive tool for liver lesion evaluation, particularly beneficial for longitudinal comparisons and standardized RECIST 1.1 reporting. Remember it's intended to support, not replace, physician judgment for diagnosis and patient management decisions. Leverage its automated volumetric analysis and registration features to enhance efficiency and consistency in your workflow.

The system is designed for seamless integration into existing radiology workflows by receiving multi-phase volume datasets from PACS devices and returning processed output in DICOM format. This ensures compatibility and efficient data exchange within a standard imaging infrastructure.

Details

Category Oncology AI
Pricing Contact for pricing
DeploymentPC-based, self-contained software application that integrates with PACS devices.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The iCAS-LV received FDA 510(k) clearance (K231690) on March 1, 2024. It is a PC-based, self-contained, noninvasive image analysis software application intended to receive multi-phase volume datasets from PACS devices, process them, and transfer the output in DICOM format. It provides tools for visualization, measurements, segmentation, annotation, image registration, processing, and reporting, supporting physicians in evaluating liver lesions.

Integrations
EHR Not specified
Specialties Nuclear Medicine, Oncology, Radiology

What the Web Says

iCAS-LV by HighRAD is an AI-powered imaging platform designed to revolutionize oncology care by accelerating and improving the accuracy of cancer detection, volumetric measurement, and longitudinal comparison of lesions in liver contrast-enhanced CT scans. It aims to streamline oncology reporting, enhance disease understanding, and ultimately improve treatment outcomes and radiologist productivity.

Overall: Positive

Strengths

  • AI-generated lesion detection for up to 3x faster oncology reporting.
  • Accurate volumetric measurement of known and unknown lesions.
  • Longitudinal comparison of findings across all available studies.
  • Automated report generation for streamlined RECIST 1.1 documentation.
  • Multi-organ view for complete standardized reporting.
  • Enhances disease understanding and improves treatment outcomes.

Limitations

  • No specific cons for iCAS-LV were found in the search results.
  • General 'ICAS' reviews (not specific to iCAS-LV or HighRAD) on platforms like Indeed and Reddit discuss challenges with management, work-life balance, and the difficulty of associated professional qualifications, but these are not relevant to the iCAS-LV product itself.

Based on reviews from: High-Rad.com, Indeed.com, Reddit, American Heart Association Journals, Capterra, G2

Last updated: 2026-07-18

Ratings & Reviews

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Press & Coverage

accessdata.fda.gov
K231690 - iCAS-LV
The FDA cleared iCAS-LV on March 1, 2024, as a PC-based, self-contained, noninvasive image analysis software application intended for trained physicians to visualize CT reconstructed images and evaluate liver lesions.
2024-03
Tracxn
HighRAD - 2026 Company Profile, Team, Funding & Competitors - Tracxn
HighRAD, founded in 2019, is a Tel Aviv-based company that develops digital image analysis and assessment tools for healthcare providers, including iCAS-LV for analyzing lesions in radiological images.
2026-05
Tracxn
Integra Holdings - 2026 Investor Profile, Portfolio, Team & Investment Trends - Tracxn
Integra Holdings is an investor in HighRAD, a company that has developed software solutions like iCAS-LV to analyze lesions in radiological images.
2026-01
Gastroenterology (via ScienceDirect)
Artificial Intelligence for the Practicing Gastroenterologist: Foundations, Contemporary Applications, Real-World Constraints
iCAS-LV by HighRAD Ltd. is listed as an AI-enabled medical device used to assess liver lesions on CT scans.
2026-07
JMIR AI (via MDPI)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
The iCAS-LV (K231690) was among the 168 ML-enabled Class II devices authorized by the FDA in 2024, cleared via the 510(k) pathway, and categorized under radiology for deep learning-based left ventricular function analysis from CT.
2025-12
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics
The iCAS-LV (K231690) from HighRAD Ltd. is referenced in a discussion about ground truthing processes for AI/ML SaMD, specifically regarding the evaluation of manual segmentations by external experts.
2025-09
Innolitics
QIH u00b7 Automated Radiological Image Processing Software u2014 FDA Product Code | Innolitics
The iCAS-LV (K231690) was cleared by the FDA on March 1, 2024, under the product code QIH for automated radiological image processing software.
2024-03
Startup Nation Finder
HighRAD Business - Startup Nation Finder
HighRAD, founded in October 2019, is a seed-stage company in Health Tech & Life Sciences that offers products like iCAS-LV for medical decision support using artificial intelligence, computer vision, and image recognition.
2024-09

Videos

Product demos, reviews, and walkthroughs for iCAS-LV.

View all on YouTube

Frequently Asked Questions

iCAS-LV is a non-invasive image analysis software that integrates with PACS devices, receiving and processing multi-phase CT volume datasets. It provides tools for visualization, measurement, segmentation, and volumetric analysis of physician-identified liver lesions, aiding in tracking changes over time.
A crucial limitation is that iCAS-LV should not be used in isolation for diagnosis or making patient management decisions. It is intended to support physicians in evaluating liver lesions by providing quantitative analysis and visualization tools, not to replace clinical judgment.
iCAS-LV has received FDA 510(k) clearance (K231690), classifying it as a Class II medical device. This clearance indicates that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.
The iCAS platform, including iCAS-LV for liver, and related products like iCAS-LG for lungs and iCAS-BR for brain, utilizes AI for quantitative volumetric changes analysis. This includes AI-generated lesion detection, accurate volumetric measurements, longitudinal comparison of findings, and automated report generation for streamlined documentation like RECIST 1.1.
Yes, the market for AI-powered oncology imaging solutions is growing, with various platforms offering tools for image analysis, segmentation, and volumetric assessment across different organs. While specific direct competitors to iCAS-LV for liver lesion analysis would require a detailed market scan, many companies offer similar AI capabilities for cancer detection, monitoring, and treatment planning.
Specific pricing for medical AI software like iCAS-LV is generally not publicly disclosed and often depends on factors such as institutional size, deployment model, and included features. Typically, it involves a licensing agreement, which could be subscription-based or a one-time purchase with ongoing maintenance fees, and is usually obtained through direct quotation from the vendor.
iCAS-LV is designed to receive and transfer DICOM formatted data from PACS devices, adhering to established medical imaging standards. While specific details on iCAS-LV's security protocols aren't explicitly detailed in the provided snippets, medical devices of this nature are expected to comply with regulations like HIPAA and GDPR, implementing robust security measures for data handling and transmission.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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