V5med Lung AI
Overview
V5med Lung AI is a Computer-Aided Detection (CAD) software designed to assist radiologists in detecting pulmonary nodules with diameters ranging from 4 to 30 mm during chest CT examinations for asymptomatic populations. The software leverages a Deep Convolutional Neural Network (CNN) based algorithm to automatically identify and highlight regions of interest with suspected lung nodules. It operates in a concurrent read mode, displaying AI analysis results alongside original CT images to provide adjunctive information and reduce the risk of overlooked findings. The system is compatible with the DICOM 3.0 standard, ensuring broad integration with various imaging equipment and PACS systems. Key functionalities include providing detailed nodule characteristics such as diameter, volume, nodule type, and Lung-RADS score. It can also compare chest CT scans taken at different time points to analyze nodule growth over time by calculating the volume doubling time (VDT), and generate comprehensive reports based on ACR Lung-RADS and Fleischner Society guidelines. Clinical studies have shown that V5med Lung AI can increase nodule detection sensitivity by over 95% and improve radiologist accuracy by up to 20%, while also reducing reading time by approximately 13%.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered lung nodule detection (4-30 mm)
- Deep Convolutional Neural Network (CNN) algorithm
- Concurrent read mode for radiologists
- Detection of ground-glass nodules (GGNs)
- PACS-integrated and vendor-neutral
- DICOM 3.0 standard compatible
- Provides nodule characteristics (diameter, volume, type, Lung-RADS score)
- Compares CT scans over time for nodule growth analysis (Volume Doubling Time)
- Generates comprehensive reports based on ACR Lung-RADS and Fleischner Society guidelines
- Reduces radiologist reading time by 13%
Use Cases
- Lung cancer screening programs
- Early detection of lung nodules
- Assisting radiologists in CT interpretation
- Monitoring nodule growth over time
- Routine chest CT workflows
What Physicians Need to Know
V5med Lung AI serves as a valuable adjunctive tool for radiologists, enhancing the detection of pulmonary nodules and improving diagnostic efficiency. Its ability to detect small nodules (4-30mm), including ground-glass nodules, and provide detailed characteristics like Lung-RADS scores, can significantly aid in early lung cancer screening and management. Physicians should integrate this tool in a concurrent read mode, leveraging its AI-generated annotations to complement their clinical judgment, rather than replacing it. The longitudinal comparison feature for nodule growth analysis is particularly useful for follow-up protocols. Ensure proper training for optimal utilization and be aware of the system's limitations, such as potential false negatives/positives under certain image quality conditions.
V5med Lung AI is designed for seamless integration into existing radiology workflows. It is highly compatible, accepting DICOM 3.0 standard images from various CT scanners, PACS, and RIS systems. The system operates on a dedicated server and displays its AI analysis results directly within the hospital's familiar DICOM Viewer interface, minimizing disruption to current reading practices. On-site installation and configuration by certified professionals ensure proper setup and connectivity within the hospital's intranet. Its vendor-neutral approach makes it adaptable to diverse clinical environments.
Details
| Category | Oncology AI, Radiology & Imaging AI |
| Pricing | Contact for pricing |
| Deployment | Offline operation, generally distributed via USB 3.0 flash drive with on-site installation by certified engineers. Installed on a server host and connected to PACS via intranet. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
1 AI-estimated V5med Lung AI received U.S. FDA 510(k) clearance (K242919) on March 27, 2025. It is a Computer-Aided Detection (CAD) software indicated for assisting radiologists in detecting pulmonary nodules (4-30 mm) during chest CT examinations for asymptomatic populations. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Pulmonology, Radiology |
What the Web Says
V5med Lung AI is a software-only, AI-powered computer-aided detection (CAD) tool designed to assist radiologists in identifying pulmonary nodules (4-30mm) in chest CT images of asymptomatic individuals. It utilizes a Deep Convolutional Neural Network (CNN) based algorithm and integrates with existing PACS/RIS systems or directly with CT scanners. Clinical studies have shown that V5med Lung AI improves radiologist performance in nodule detection, reduces reading time, and enhances inter-reader agreement. The system received U.S. FDA 510(k) clearance in March 2025.
Overall: PositiveStrengths
- Improved nodule detection sensitivity, with a 10% reduction in missed cancers compared to unaided reads.
- Reduced radiologist interpretation time by an average of 13%.
- Enhanced inter-reader agreement among radiologists of different experience levels.
- Broad compatibility with various imaging equipment due to DICOM 3.0 standard adherence.
- Designed for seamless integration into diverse clinical environments and existing PACS/RIS systems.
- FDA-approved, indicating adherence to rigorous regulatory standards.
Limitations
- Not intended to replace a radiologist's critical judgment or diagnostic processes and should not be used in isolation.
- Not applicable for patients with obvious abnormalities like large thoracic tumors (>30mm), diffuse lung metastasis, malignant pleural effusion, or those with a history of lung tumors, lung surgery, or interstitial lung disease.
- Potential for software malfunction or data compromise if the computer is infected with malware.
- Installation requires on-site delivery and setup by factory engineers or certified dealers.
- Racial diversity in pivotal study skewed (92.8% White), reflecting the NLST source population.
- Standalone performance metrics (sensitivity, specificity) are not fully disclosed in public summaries, only relative to predicate devices.
Based on reviews from: V5med Lung AI (v5med.com), V5med Lung AI | FDA Radiology AI Device - X-ray Interpreter, K242919 - Ining Cheng - accessdata.fda.gov, V5med's AI Lung Nodule Detection System Receives U.S. FDA Approval | Healthcare+ B2B, Clinical Evaluation of the V5-LU01 AI Software in Thoracic CT for V5med Inc. - CenterWatch, V5 Technologies nets TFDA approval of Lung Image Aided Interpretation Software, V5med Lung AI - OncologyAI Registry, Transforming Lung and Heart Diagnostics with Clinically Proven AI. - V5med Inc. Introduction, V5med Inc. Introduction, Artificial Intelligence Assisted Computational Tomographic Detection of Lung Nodules for Prognostic Cancer Examination: A Large-Scale Clinical Trial - PMC, (PDF) Artificial Intelligence Assisted Computational Tomographic Detection of Lung Nodules for Prognostic Cancer Examination: A Large-Scale Clinical Trial - ResearchGate
Last updated: 2026-07-20
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate V5med Lung AI
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for V5med Lung AI.
Taiwanu2019s Smart Healthcare Revolution Breakthroughs at Taiwan Expo USA 2025
USA Insider
