Lung AI

JSON twin: https://www.healthaidb.com/software/lung-ai.json

Company Name

V5med

Product URL

https://www.v5med.com/en/archives/267

Company URL

https://www.v5med.com

Categories

• diagnostic Support
• clinical Care
• radiology
• oncology Care
• ai Clinical Documentation Integrity
• imaging Software
• clinical Decision Support
• healthcare Software Solutions
• regulatory Compliance
• Diagnostic
• Clinical
• Oncology
• Ai-powered
• Medical Imaging
• Computer-aided Detection
• Lung Cancer Screening
• Healthcare Software
• Fda-cleared

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.

Api Available

unknown

Certifications

• FDA 510(k) clearance (e.g., K242919)

Company Founding

2021

Company Offices

• Taiwan
• United States

Compliance

• HIPAA
• FDA 510(k) clearance

Customers

• Summa Health

Data Residency

Supports multi-region options; region selection available per deployment

Data Standards

• DICOM
• HL7 v2
• FHIR

Deployment Model

• SaaS
• on_prem

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

Id

SW0036

Integration Partners

Integrations

• PACS
• RIS
• CT scanners
• Radiology workstations

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

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

Optional Modules

• Advanced volumetric growth analysis
• Population screening dashboard/analytics
• Enterprise deployment/PACS connector services

Os Platforms

• Web
• Windows
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• Data anonymization/de-identification
• Data processing agreements/BAA available
• Patient-consent aware workflow support

Product Code

SW0036

Product Name

Lung AI

Ratings

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

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Data encryption in transit and at rest
• Role-based access control (RBAC)
• Audit logs/activity logging
• SSO/SAML integration

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

Support Channels

System Requirements

Compatible with multi-vendor CT scanners and non-contrast images; integrates with PACS, RIS, or CT scanners; outputs DICOM GSPS for visualization

Target Users

• clinicians
• radiologists
• patients
• admins
• payers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "V5med",
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  "company_url": "https://www.v5med.com",
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  "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.",
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  "specialties": [
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    "Oncology",
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    "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"
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  "regions_available": [
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    "India",
    "United States",
    "North America",
    "Latin America",
    "Middle East",
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    "Australia",
    "New Zealand",
    "Japan",
    "South Korea",
    "China",
    "Hong Kong",
    "Macau",
    "Singapore",
    "Malaysia",
    "Indonesia",
    "Philippines",
    "Thailand"
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  "languages_supported": [
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    "Hindi",
    "Bengali",
    "Punjabi",
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    "Tamil",
    "Urdu",
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    "Thai",
    "Filipino",
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  "pricing_model": "subscription",
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  "license": "commercial",
  "company_offices": [
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  "company_founding": "2021",
  "deployment_model": [
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  "os_platforms": [
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  "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": [
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    "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"
  ],
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  "customers": [
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  "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",
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}