RevealDx
by RevealDx
· Based in United States →
— Dramatically improve lung cancer outcomes using non-invasive diagnosis.
Reimbursable by medicare for us clinical use at a rate of $650.
Overview
RevealAI-Lung by RevealDx is an AI-powered Computer-Aided Diagnosis (CADx) software designed to assist radiologists in evaluating incidental lung nodules on chest CT scans.
- What it does: The software generates a Malignancy Similarity Index (mSI), a quantitative score that characterizes a detected lung nodule and provides a risk assessment. This score is intended to support clinicians in making informed follow-up recommendations.
- Who it is for: RevealAI-Lung is primarily for radiologists and other healthcare professionals involved in lung nodule assessment and lung cancer screening programs.
- How it fits a clinical or practice workflow: A notable feature is its direct integration into Picture Archiving and Communication Systems (PACS), aiming to minimize disruption to existing routines. The mSI can be computed with a single click and results are displayed within seconds, allowing for integration into the radiology report.
- Notable capabilities: The software utilizes real-world data from the National Lung Screening Trial (NLST) as a reference population for its scoring. It is designed to be generalizable across different exam types and patient populations. RevealDx has also partnered with other companies for distribution and integration, including Sirona Medical and Riverain Technologies.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered lung nodule characterization
- CT scan analysis
- Differentiation of benign vs. malignant nodules
- Quantitative and qualitative data insights
- Integration into clinical workflows
- Supports diagnostic confidence
- Non-invasive assessment
Use Cases
- Early lung cancer detection
- Lung nodule management
- Reducing unnecessary invasive procedures
- Enhancing diagnostic accuracy in radiology
- Supporting treatment planning in oncology
What Physicians Need to Know
Evidence Base
RevealAI-Lung utilizes real-world data from the National Lung Screening Trial (NLST) as a reference population for its Malignancy Similarity Index (mSI) scoring. The technology is built upon proprietary analytics, patented algorithms, and ensemble classification techniques coupled with layers of radiomic features for in-depth analysis. RevealDx has published several studies demonstrating the technology's ability to improve early cancer detection rates and reduce false positives.
Clinical Validation Studies
RevealAI-Lung has been validated on data from over 1,500 patients across diverse cohorts. Studies have shown a significant improvement in radiologist performance, as measured by the area under the curve (AUC). Clinical studies indicate that the use of the RevealDx mSI feature can detect cancer up to one year sooner in approximately 45% of cases, while simultaneously reducing false positive detection rates by 18%. In a study population of 1,530 patients with lung nodules, 40% of cancers were diagnosed earlier due to the use of mSI. The company's website lists several clinical validation studies, including those on the clinical impact and generalizability of the tool, and its benefit for lung nodules in the UK.
Alert Fatigue Management
While RevealDx's core product, RevealAI-Lung, provides a Malignancy Similarity Index (mSI) score to aid in decision-making, the available information does not specifically detail features for alert fatigue management within the RevealDx software itself. Generally, alert fatigue in clinical decision support tools is a known issue, where a high volume of low-value alerts can lead to desensitization and missed critical warnings. Effective alert fatigue management often involves increasing alert specificity, tailoring alerts to patient characteristics, tiering alerts by severity, and regularly reviewing the alert system.
Differential Diagnosis Support
RevealAI-Lung generates a Malignancy Similarity Index (mSI), a quantitative score (0-1) that characterizes a detected lung nodule and indicates the degree of similarity between the nodule in question and nodules with known outcomes in a reference set. This risk assessment aims to support clinicians in making more informed and consistent follow-up recommendations, potentially leading to earlier cancer diagnosis. A high mSI can indicate 'upgrading' follow-up compared to guideline recommendations due to increased certainty of malignancy, while a low mSI can suggest 'downgrading' to reduce unnecessary invasive procedures.
Clinical Workflow Integration
RevealAI-Lung is designed to integrate directly into Picture Archiving and Communication Systems (PACS), aiming to minimize disruption to radiologists' existing routines. The system is designed for single-click operation, where the mSI is computed and displayed within a few seconds. The mSI value is also available to be integrated into the radiology report. RevealDx has announced integrations with various PACS providers, including Fujifilm's PACS, and partnerships with companies like Riverain and Sirona Medical to embed its algorithm into their platforms, allowing for a streamlined lung workflow.
Decision Audit Trail
The provided information does not specifically detail a 'Decision Audit Trail' feature within RevealDx's RevealAI-Lung software.
Physician Tip
RevealAI-Lung provides a Malignancy Similarity Index (mSI) to help characterize lung nodules, offering an objective, quantitative score to inform your clinical decision-making. This can assist in making more informed and consistent follow-up recommendations, potentially leading to earlier cancer diagnosis and reducing unnecessary invasive procedures. The software is designed for seamless integration into your existing PACS workflow with single-click operation for quick results. Consider the mSI score as an augmentative tool, providing additional radiomic insights that may be invisible to the human eye, thereby enhancing your diagnostic precision.
RevealDx's RevealAI-Lung is designed for direct integration into Picture Archiving and Communication Systems (PACS) to minimize workflow disruption. The company has established partnerships and integrations with key industry players, including Riverain Technologies, Fujifilm's PACS, Sirona Medical, and contextflow. These collaborations aim to embed RevealAI-Lung's capabilities into broader radiology platforms and lung CT solutions, enabling a more streamlined and comprehensive lung nodule assessment workflow. RevealDx also has distribution agreements with companies like Sirona and 4DMedical for wider market availability.
Details
| Category | Clinical Decision Support & Reference, Lab & Diagnostics, Radiology & Imaging AI |
| Pricing | Reimbursable by medicare for us clinical use at a rate of $650. — RevealAI-Lung is reimbursable by Medicare under CPT codes 0721T and 0722T. |
| Deployment | Integrates directly into PACS. |
| Mobile App | None |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Unknown AI-estimated RevealDx has secured FDA clearance for RevealAI-Lung, an AI-driven software that helps radiologists assess incidental lung nodules using a validated malignancy scoring system. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Pulmonology, Radiology, Thoracic Surgery |
Social Proof
| Customers | At least 4 customers in Europe as of July 2024. Deployed across hundreds of leading health systems through partnership with Azra AI. |
What the Web Says
RevealDx is an AI-powered diagnostic platform focused on early lung cancer detection from CT scans. Reviews highlight its potential to improve diagnostic accuracy and speed, aiding physicians in identifying suspicious nodules that might be missed by the human eye. The technology aims to reduce false positives and negatives, leading to earlier intervention and better patient outcomes.
Overall: PositiveStrengths
- Early detection of lung cancer, potentially improving patient survival rates.
- AI-driven analysis can identify subtle abnormalities missed by human review.
- Aids in reducing diagnostic variability among radiologists.
- Streamlines workflow and potentially reduces the burden on radiologists.
- Focus on a critical and high-impact disease area.
- Potential for integration with existing PACS systems.
Limitations
- Relatively new technology, long-term efficacy and real-world impact still being evaluated.
- Potential for 'alert fatigue' if the AI generates too many findings that are ultimately benign.
- Integration challenges with diverse healthcare IT infrastructures.
- Cost of implementation and ongoing maintenance for healthcare providers.
- Reliance on high-quality imaging data for accurate analysis.
- Ethical considerations around AI in diagnostics and physician responsibility.
Based on reviews from: Reveal-AI.com (product information), Healthcare IT News, Radiology Today, Medical journals/studies on AI in diagnostics, Physician forums (general discussions on AI in radiology), Tech review sites (general AI in healthcare discussions)
Last updated: 2026-08-23
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate RevealDx
Press & Coverage
Imaging Technology News
RevealDx Gets FDA Clearance for RevealAI-Lung
RevealDx announced FDA clearance for RevealAI-Lung, an AI-powered software that characterizes lung nodules with a Malignancy Similarity Index (mSI) to aid in cancer diagnosis. This follows their MDR certification in November 2025 and makes the software reimbursable in the U.S. using codes 0721T and 0722T.
2026-02
Pulse 2.0
RevealDx Secures $3.4 Million Investment From 4DMedical And Signs Global Distribution Agreement For RevealAI-Lung
RevealDx received a $3.4 million strategic investment from 4DMedical and signed a global distribution agreement for its RevealAI-Lung software, expanding its reach across the U.S., Europe, Australia, and New Zealand. The software helps radiologists make informed follow-up recommendations for potentially cancerous lung nodules.
2026-08
Medical Device Network
RevealDx wins FDA clearance for lung nodule assessment software
RevealDx, a Seattle-based medical imaging company, received FDA clearance for its RevealAI-Lung software, designed to help radiologists assess lung nodule cancer risk and improve early detection. The software provides a Malignancy Similarity Index (mSI) and is now commercially available in the U.S.
2026-02
AuntMinnieEurope
RevealDx secures MDR certification for RevealAI-Lung
RevealDx obtained EU Medical Device Regulation (MDR) certification for its RevealAI-Lung software, which characterizes lung nodules using a Malignancy Similarity Index (mSI) to reduce diagnosis time and false positives. The software is distributed in the EU by contextflow.
2025-11
GeekWire
Seattle startup RevealDx lands $4.2M to help clinicians diagnose lung cancer
RevealDx, a Seattle-based startup, raised $4.25 million in a new investment round to advance its software that uses machine learning to assess the probability of lung nodules being cancerous. The company, previously known as Mindshare Medical, aims to accelerate diagnosis and reduce false positives.
2024-07
Healio
FDA clears lung nodule risk assessment software powered by AI
The FDA cleared RevealDx's AI-powered RevealAI-Lung software, which generates a Malignancy Similarity Index (mSI) score to help radiologists assess lung nodule risk. Studies showed that the mSI led to earlier cancer diagnoses in 40% of cases and a 22% drop in false positives.
2026-02
RevealDx (Press Release)
RevealDx and contextflow team up to improve lung cancer screening in the EU via enhanced nodule characterization
RevealDx partnered with contextflow for exclusive distribution of its RevealAI-Lung software in the EU, integrating its CADx technology for lung nodule characterization into contextflow's SEARCH Lung CT platform. This collaboration aims to enhance lung cancer screening by providing both quantification and classification of lung nodule types.
2022-08
PMC (Peer-Reviewed Journal)
Artificial Intelligence Tools in Precision Lung Cancer Care: From Early Detection to Clinical Decision Support
This peer-reviewed article discusses the role of AI in lung cancer care, citing RevealDx's RevealAI-Lung as an FDA-approved AI-based lung cancer screening tool. It highlights the evolution of AI-driven tools from proof-of-concept to clinically deployable systems for improved diagnostics and risk stratification.
2026-05
Videos
Product demos, reviews, and walkthroughs for RevealDx.
JACR Paper Overview RevealDx
RevealDx
Beyond Detection: How RevealDX Uses AI to Tackle Lung Cancer (ft. CEO Chris Wood)
HealthTech Remedy
RevealAI-Lung Demonstration
RevealDx
RevealDX at AngelMD Pitch Club (September 28, 2021)
AngelMD Inc
RevealAI Lung
RevealDx
Episode 60: How to make money from medical AI, with Chris Wood, CEO of RevealDX
Felix Beacher
Frequently Asked Questions
RevealDx is a Seattle-based software company that provides AI-enabled lung cancer decision support software, specifically RevealAI-Lung. It characterizes incidental lung nodules by generating a Malignancy Similarity Index (mSI) score, which helps radiologists assess the likelihood of cancer and make more informed follow-up recommendations.
RevealAI-Lung has received FDA clearance in the US (January 2026) and MDR Certification in Europe (November 2025). It also has market authorization for clinical use in Canada, Australia, New Zealand, and is registered for use in the UK.
RevealAI-Lung is designed for single-click operation and integrates directly into Picture Archiving and Communication Systems (PACS), minimizing disruption to radiologists' routines. Key features include generating the mSI score, providing actionable radiomic insights, and supporting consistent follow-up recommendations.
Benefits include accelerating diagnosis, reducing false positives, potentially identifying malignant nodules earlier, and decreasing unnecessary procedures, which can lead to significant cost savings. While the software is validated on over 1,500 patients, it is intended to complement other clinical information rather than provide an independent diagnosis.
In the US, RevealAI-Lung is reimbursable by Medicare under the Outpatient Prospective Payment System (OPPS) using codes 0721T and 0722T, at a rate of approximately $650. Specific pricing plans for direct purchase are not publicly detailed, but the company emphasizes significant cost savings through reduced unnecessary procedures.
Yes, there are several alternatives in the market. Some companies offering AI-powered lung nodule solutions include contextflow (ADVANCE Chest CT), Riverain (ClearRead CT), Qure AI (qCT-Lung & qCT LN Quant), Coreline (AVIEW LCS), and DeepHealth (Chest Suite). Other general EHR and practice management alternatives mentioned include Epic, Carepatron, and ModMed.
RevealDx states that its software has been extensively validated in clinical trials and years of research, including validation on over 1,500 patients from various cohorts. Studies have demonstrated its ability to improve early cancer detection rates and reduce false positives.
Suggest an Edit →
| Last Verified: 2026-08-24 | First Added: 2026-08-23