VisiRad XR
Overview
VisiRad XR, developed by Imidex, is an AI-powered software as a medical device (SaMD) designed to assist radiologists in detecting lung nodules and masses on chest radiographs. It analyzes DICOM images, utilizing machine learning algorithms to identify and mark suspicious regions ranging from 6-60mm. The software functions as a ‘second-read’ tool, intended to be used by clinicians after their initial interpretation, thereby enhancing detection rates and potentially reducing radiologist burnout. VisiRad XR seamlessly integrates into existing radiology workflows, routing images with AI-detected lesions back to radiologists within their native viewing environment for interpretation. Imidex announced the sale of VisiRad XR and its associated intellectual property in April 2025.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered lung nodule and mass detection (6-60mm) on chest X-rays
- Analyzes chest X-rays for suspicious regions
- Integrates into current radiology workflow
- Provides a 'second-read' for clinicians after initial interpretation
- Outputs secondary DICOM with annotated regions of interest
- Cloud-based software for accessibility and scalability
- Operates on both AP and PA image views
- Compatible with multiple chest radiograph hardware systems
- Demonstrated 83% sensitivity in detecting lung nodules and masses in studies
- Improved reader performance (AUC and sensitivity) in clinical validation studies
Use Cases
- Early detection and identification of lung cancer
- Aid for radiologists in identifying subtle lung nodules and masses
- Reducing radiologist workload and potential burnout
- Improving patient outcomes by facilitating earlier diagnosis of lung cancer
- Incidental and broad population screening of lung nodules and masses using routine chest X-rays
- Enhancing detection of lung nodules and masses in outpatient and emergency department settings
What Physicians Need to Know
VisiRad XR serves as a valuable 'second-read' tool for chest X-rays, aiding in the detection of subtle lung nodules and masses that might otherwise be overlooked. Physicians should integrate this AI assistance after their initial interpretation, leveraging it to enhance diagnostic accuracy and potentially identify lung cancers at earlier, more treatable stages. Remember, it is an aid and does not replace the radiologist's professional judgment or intended for primary diagnosis or triage. Its use can be particularly beneficial in high-volume settings to combat burnout and improve overall detection rates.
VisiRad XR is designed for straightforward integration into existing radiology workflows, delivering AI-annotated images directly within the radiologist's native viewing environment via standard DICOM protocols. Its foundation on Google Cloud Vertex AI ensures a scalable and secure platform. Recent partnerships with companies like Spesana and Orbit Genomics suggest a future trajectory towards broader integration within personalized medicine platforms and genomics for a more comprehensive approach to lung cancer detection and patient care.
Details
| Category | Oncology AI, Radiology & Imaging AI |
| Pricing | Not disclosed — Not disclosed |
| Deployment | Cloud-based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated VisiRad XR received FDA 510(k) clearance (K223133) on August 3, 2023, as a Class II Medical Image Analyzer (Product Code MYN). It is cleared as a computer-aided detection (CADe) device intended to identify and mark regions of interest suspicious for lung nodules and masses from 6-60mm in chest radiographs, to be used as a second-read only. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Pulmonology, Radiology |
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