{"product_name":"iCAS-LV","company_name":"HighRAD","product_url":"https://www.highrad.com/icas-lv","company_url":"https://www.highrad.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0247","summary":"iCAS-LV™ is an AI-driven software by HighRAD that automates lesion detection and volumetric analysis in liver CT scans, enhancing oncology reporting efficiency and accuracy.","description":"iCAS-LV™ is an AI-powered software solution developed by HighRAD to automate the detection and volumetric analysis of lesions in liver contrast-enhanced CT (ceCT) scans. It aims to expedite oncology reporting by up to three times and streamline RECIST 1.1 documentation. The software provides accurate volumetric measurements for both known and unknown lesions, offers a multi-organ view for standardized reporting, and enables longitudinal comparison of findings across multiple studies. Performance metrics include an average lesion recall of 0.92±0.14 and a segmentation (Dice) score of 0.86±0.09.","categories":["clinical Care","imaging Software","oncology Care","radiology","Clinical","Diagnostic Imaging","Oncology","Medical Imaging","Radiology"],"market_segment":["Enterprise","SMB"],"target_users":["Radiologists","Oncologists","Medical Imaging Professionals"],"specialties":["Oncology","Radiology","Medical Imaging"],"regions_available":["Global"],"languages_supported":["English"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["Israel"],"company_founding":"2019","deployment_model":["on_prem"],"os_platforms":["Windows"],"features":["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","Quantitative analysis of lesion volume and diameter changes over time","Processing of multi-phase CT volume datasets in DICOM format","Output of quantitative data to PACS systems"],"optional_modules":[],"integrations":["PACS systems"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Windows PC","compliance":["HIPAA","FDA 510(k)"],"certifications":["FDA 510(k)"],"security_features":["Encryption","Audit logs"],"privacy_features":["BAA available","Data anonymization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0247","slug":"icas-lv","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/icas-lv.json"}}