{"product_name":"Lung-CAD","company_name":"Imagen Technologies","product_url":"https://www.imagen-tech.com","company_url":"https://www.imagen-tech.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0308","summary":"Lung-CAD is an AI-driven software developed by Imagen Technologies to assist physicians in detecting lung hyperinflation and interstitial thickening in chest X-rays, enhancing diagnostic accuracy without replacing clinical judgment.","description":"Lung-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for lung hyperinflation and interstitial thickening. Utilizing deep learning algorithms, it identifies regions of interest (ROIs) and produces bounding boxes around these areas. Intended as a concurrent reading aid for physicians interpreting chest X-rays, Lung-CAD is not designed for clinical diagnosis and is indicated for adult patients only. The device operates on a secure cloud-based platform and integrates seamlessly into existing X-ray reading workflows without the need for new PACS technology or costly re-training of physicians. Performance testing includes software verification and validation following FDA guidance, standalone testing on 5,000 chest X-rays demonstrating high sensitivity (0.898), specificity (0.894), and AUC (0.964), and a clinical multiple reader, multiple case (MRMC) retrospective study showing statistically significant reader performance improvement with Lung-CAD assistance in detecting lung hyperinflation (p<0.001).","categories":["diagnostic Support","clinical Care","radiology","imaging Software","clinical Decision Support","Diagnostic","Clinical","Radiology","Ai-assisted Detection"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","primary care physicians"],"specialties":["Pulmonology","Radiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2019","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-based analysis of chest X-ray images","Detection of lung hyperinflation regions","Bounding box overlays on X-ray images","Concurrent reading aid for physicians","Deep learning algorithm for image analysis","Cloud-based platform operation","Integration with PACS viewers","High sensitivity and specificity in detection","Statistically significant reader performance improvement","FDA 510(k) clearance for lung hyperinflation detection","Intended for adult patients only"],"optional_modules":[],"integrations":["PACS viewers"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Cloud-based platform","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance"],"security_features":["Encryption","Audit logs"],"privacy_features":["Data anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":["They are very keen to improve the platform and listen to our comments. Also, the support service is excellent and fixes issues very quickly. I think the service is very adaptive and can cater to each client's needs, which we like a lot.","The ability to media log files on the platform has made it easier for PAC12 schools to search and download files. The user-friendly platform has taken a load off of our production departments which in the past would send files to our schools manually. Account Managers and Support Teams are always available."],"ratings":["\"4/5\" from G2 review by Guy P., Digital Platform Coordinator, Small-Business (50 or fewer employees), November 15, 2022","\"5/5\" from G2 review by Brian C., Media Manager, Enterprise (> 1000 employees), November 8, 2022"],"support_channels":[],"training_options":[],"release_year":"\"\"","integration_partners":[],"id":"SW0308","slug":"lung-cad","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/lung-cad.json"}}