{"product_name":"Lung AI","company_name":"V5med","product_url":"https://www.v5med.com/en/archives/267","company_url":"https://www.v5med.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0036","summary":"V5med's Lung AI is an FDA-cleared, AI-powered system that assists radiologists in detecting and evaluating pulmonary nodules in low-dose CT scans, enhancing diagnostic accuracy and efficiency.","description":"V5med's Lung AI is an FDA-cleared computer-aided detection (CADe) system designed to support low-dose CT (LDCT) lung cancer screening workflows. It assists radiologists by automatically annotating nodules, providing real-time measurements—including diameter, volume, type (e.g., GGN), and Lung-RADS® classification. The system also supports longitudinal image comparison, aligning nodules across different timepoints and quantifying growth trends such as volume doubling time (VDT). Final reports are automatically generated based on ACR Lung-RADS and Fleischner Society guidelines, offering structured recommendations to support clinical decision-making and improve consistency in patient communication and follow-up planning. Clinical validation has demonstrated exceptional sensitivity and accuracy, with an overall sensitivity of 95.6%, 92.8% for 4–5mm nodule detection, and 95.7% for GGO nodule detection. The system has been adopted by over 40 hospitals across Taiwan and has expanded into key markets across Southeast Asia and India. In March 2025, it received U.S. FDA 510(k) clearance, marking the first Taiwanese company to obtain such approval for low-dose CT-based lung cancer screening. V5med plans to expand into North America, Latin America, the Middle East, and other global markets. The company was founded in 2021 and has offices in Taiwan and the United States.","categories":["diagnostic Support","clinical Care","radiology","oncology Care","ai Clinical Documentation Integrity","imaging Software","oncology Care","clinical Decision Support","healthcare Software Solutions","regulatory Compliance","Diagnostic","Clinical","Radiology","Oncology","Ai-powered","Medical Imaging","Computer-aided Detection","Lung Cancer Screening","Healthcare Software","Fda-cleared"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","radiologists","patients","admins","payers"],"specialties":["Radiology","Oncology","Pulmonology","Thoracic Surgery","Internal Medicine","Family Medicine","Geriatrics","Palliative Care","Emergency Medicine","Pathology","Medical Imaging","Healthcare It","Healthcare Administration","Healthcare Policy","Healthcare Research","Healthcare Education","Healthcare Consulting","Healthcare Marketing","Healthcare Sales","Healthcare Operations","Healthcare Finance"],"regions_available":["Taiwan","Southeast Asia","India","United States","North America","Latin America","Middle East","Europe","Africa","Australia","New Zealand","Japan","South Korea","China","Hong Kong","Macau","Singapore","Malaysia","Indonesia","Philippines","Thailand"],"languages_supported":["English","Mandarin Chinese","Taiwanese Hokkien","Hakka","Japanese","Korean","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati","Malay","Thai","Filipino","Vietnamese","Burmese","Khmer","Lao"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Taiwan","United States"],"company_founding":"2021","deployment_model":["SaaS","on_prem"],"os_platforms":["Web","Windows","Linux"],"features":["Automated detection and annotation of pulmonary nodules in chest CT images","Real-time measurements including diameter, volume, type (e.g., GGN), and LungRADS® classification","Longitudinal image comparison with precise nodule alignment across timepoints","Quantification of growth trends such as volume doubling time (VDT)","Automated report generation based on ACR Lung-RADS and Fleischner Society guidelines"],"optional_modules":["Advanced volumetric growth analysis","Population screening dashboard/analytics","Enterprise deployment/PACS connector services"],"integrations":["PACS","RIS","CT scanners","Radiology workstations"],"data_standards":["DICOM","HL7 v2","FHIR"],"api_available":"unknown","system_requirements":"Compatible with multi-vendor CT scanners and non-contrast images; integrates with PACS, RIS, or CT scanners; outputs DICOM GSPS for visualization","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance (e.g., K242919)"],"security_features":["Data encryption in transit and at rest","Role-based access control (RBAC)","Audit logs/activity logging","SSO/SAML integration"],"privacy_features":["Data anonymization/de-identification","Data processing agreements/BAA available","Patient-consent aware workflow support"],"data_residency":"Supports multi-region options; region selection available per deployment","customers":["Summa Health"],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0036","slug":"lung-ai","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/lung-ai.json"}}