RevealAI-Lung

by Precision Medical Ventures, Inc. Dba Revealdx  · Based in United States → — Informing Precision Medicine. Imagine diagnosing cancer, even what specific type of cancer, non-invasively. This is especially important in the Lung, where biopsies and surgeries have high morbidity and mortality rates.
Oncology Pulmonology Radiology
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Overview

RevealAI-Lung is an AI-powered, computer-aided diagnostic (CADx) software application designed to assist clinicians in the assessment and characterization of incidentally-detected lung nodules on computed tomography (CT) scans. The software analyzes lung CT images and generates a Malignancy Similarity Index (mSI) score, which helps radiologists make more informed follow-up recommendations to assist in cancer diagnosis. The mSI score is intended for the evaluation of incidentally-detected pulmonary nodules with a diameter of 6-15mm in patients aged 18 years or above. RevealAI-Lung compares features from the selected nodule to a reference image database derived from National Lung Cancer Screening Trial (NLST) patient cases. The software is integrated directly into Picture Archiving and Communication Systems (PACS), aiming to improve workflow.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Malignancy Similarity Index (mSI) score generation
  • Single-click operation for mSI computation
  • Integration with PACS for streamlined workflow
  • Actionable radiomic insights
  • Comparison of nodules to a reference image database (NLST data)
  • Improved stability across image types
  • Transparency of predictions
  • Significant cost savings by reducing unnecessary procedures
  • Graphs to interpret nodule relation to confirmed malignant/benign nodules
  • Generalizability across exam types and patient populations

Use Cases

  • Lung nodule risk assessment
  • Early lung cancer assessment
  • Assisting radiologists in follow-up recommendations for lung nodules
  • Reducing delayed cancer diagnoses
  • Reducing false positives in lung nodule management
  • Improving nodule classification in incidental lung nodules

What Physicians Need to Know

Key Capabilities
RevealAI-Lung is a Computer Assisted Diagnostic (CADx) software that characterizes incidentally-detected lung nodules on CT scans. It provides a Malignancy Similarity Index (mSI) by comparing nodule characteristics to a clinically established database, aiding in cancer risk assessment. The software offers actionable radiomic insights and graphs to interpret how lung nodules relate to confirmed malignant or benign nodules. It is designed for single-click operation and provides results within seconds.
Clinical Utility
The mSI score assists clinicians in assessing patients' cancer risk and making more informed follow-up recommendations, potentially leading to earlier cancer diagnosis and fewer unnecessary procedures. It is indicated for evaluating incidentally-detected pulmonary nodules with a diameter of 6-15mm in patients aged 18 years or above. Studies suggest it can reduce delayed cancer diagnoses and improve nodule classification when combined with existing guidelines.
Integration Options
RevealAI-Lung is designed for integration into standard reading environments like Picture Archiving and Communication Systems (PACS), allowing clinicians to access analytics without leaving their workflow. It can be deployed as a cloud-based solution or locally on dedicated hardware. The software has announced integrations with Riverain, Fujifilm's PACS, and Sirona's unified radiology platform.
Compliance Status
The software has received FDA clearance (Class II, 510(k) cleared) in the US and CE certification (Class IIb, MDR pathway) in Europe. It is also TGA approved in Australia and has a Health Canada medical device license.
Pricing Model
RevealAI-Lung operates on a subscription-based pricing model, which is based on the number of analyses performed. In the US, it is reimbursable under the Medicare Outpatient Prospective Payment System (OPPS) at a rate of $650 using codes 0721T and 0722T.
User Experience
The software is designed for a streamlined workflow with single-click operation to compute the mSI, and results are displayed within a few seconds. The user interface includes the mSI score and a histogram for interpreting case distributions.
Evidence Base
RevealAI-Lung has been validated on over 1,500 patients from various cohorts. Its development and training utilized imaging data from the National Lung Cancer Screening Trial (NLST). The technology is supported by several peer-reviewed papers and clinical studies demonstrating its ability to improve early cancer detection rates and reduce false positives.
Physician Tip

When utilizing RevealAI-Lung, interpret the Malignancy Similarity Index (mSI) as a relative risk score in conjunction with established clinical guidelines and other patient-specific factors. The provided graphs can offer valuable context by showing how the current patient's lung nodules compare to confirmed malignant or benign cases. The software is intended to augment, not replace, a radiologist's expertise in making final patient management decisions. Focus on the efficiency gains from its PACS integration and quick analysis time to streamline your workflow for incidental lung nodule characterization.

RevealAI-Lung's strength lies in its direct integration capabilities with existing PACS, minimizing workflow disruption. It has established partnerships with key players like Riverain for nodule detection, Fujifilm for PACS, and Sirona for a unified radiology platform, indicating a commitment to interoperability within diverse imaging ecosystems. This allows for seamless incorporation of the mSI score into radiology reports and potentially into RIS systems.

Details

Category Oncology AI
Pricing Subscription
  • Based on number of analyses; Reimbursable in the US under Medicare Outpatient Prospective Payment System (OPPS) at a rate of $650 using codes 0721T and 0722T
DeploymentOn-premise server or cloud-based systems securely connected to facility network
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated

RevealAI-Lung received US Food and Drug Administration (FDA) 510(k) clearance on January 30, 2026, for lung nodule risk assessment. It is a Computer-Assisted Diagnostic (CADx) software intended for the characterization of incidentally-detected lung nodules on CT scans.
Integrations
EHR Not specified
Specialties Oncology, Pulmonology, Radiology

What the Web Says

RevealAI-Lung is an AI-powered software designed to assist radiologists in assessing lung nodules and determining cancer risk. It generates a Malignancy Similarity Index (mSI) score by comparing nodule characteristics to a database of known outcomes. The software aims to improve early cancer detection, reduce false positives, and streamline workflow by integrating directly into Picture Archiving and Communication Systems (PACS).

Overall: Positive

Strengths

  • Earlier diagnosis of lung cancer (up to 40% in studies)
  • Reduction in false positives (up to 22% in studies)
  • Provides a Malignancy Similarity Index (mSI) score to aid risk assessment
  • Integrates directly into PACS, improving workflow
  • Clinically validated in multi-center studies
  • First radiology AI to be reimbursed in Europe (starting in Germany)

Limitations

  • The mSI score is a relative risk score, not a percentage cancer risk
  • Not indicated for use by pulmonologists; only intended for radiologists
  • Not intended for screen-detected nodules
  • Learning the SDK for integration might not be a plug-and-play experience for custom setups

Based on reviews from: Healio, contextflow, Health AI Register, G2, Medical Product Outsourcing, Imaging Technology News, Axis Imaging News, accessdata.fda.gov

Last updated: 2026-08-19

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Press & Coverage

Imaging Technology News
RevealDx Gets FDA Clearance for RevealAI-Lung | Imaging Technology News
RevealDx announced FDA clearance for RevealAI-Lung on February 3, 2026, a software that characterizes lung nodules with a Malignancy Similarity Index (mSI) to help radiologists make informed follow-up recommendations. The company had previously received MDR certification in November 2025 and validated the software on over 1,500 patients.
2026-02
Healio
FDA clears lung nodule risk assessment software powered by AI - Healio
RevealDx's AI-powered RevealAI-Lung software, which assesses lung nodule malignancy risk, received FDA clearance. The software generates a Malignancy Similarity Index (mSI) score, and studies showed it led to earlier cancer diagnoses in 40% of cases and a 22% drop in false positives.
2026-02
Medical Device Network
FDA clears RevealDX's AI lung nodule diagnostic - Medical Device Network
RevealDX has secured FDA clearance for RevealAI-Lung, an AI-based software for lung nodule risk assessment, making it reimbursable in the US under Medicare at $650. The software assigns a Malignancy Similarity Index (mSI) to lung nodules to aid radiologists in cancer diagnosis.
2026-02
Medical Product Outsourcing
FDA Clears AI-Powered Lung Nodule Risk Assessment Tool | Medical Product Outsourcing
RevealDx received FDA clearance for RevealAI-Lung, an AI-powered tool for detecting malignant lung nodules, following its MDR Certification in November. The software provides a Malignancy Similarity Index (mSI) to inform clinical decision-making and reduce unnecessary procedures.
2026-02
RevealDx Press Release
RevealDx Receives FDA Clearance for AI Powered Lung Nodule Risk Assessment
RevealDx announced FDA clearance for RevealAI-Lung on February 3, 2026. This AI tool for lung nodule characterization produces a Malignancy Similarity Index (mSI) to help radiologists with follow-up recommendations, and it is now reimbursable by Medicare.
2026-02
unknown
RevealDx wins FDA clearance for lung nodule assessment software
RevealDx received FDA clearance for its RevealAI-Lung software, which uses AI to assess lung nodule cancer risk and improve early detection. The software integrates directly into PACS and uses real-world data from the National Lung Screening Trial.
2026-02
Pulse 2.0
RevealDx Secures $3.4 Million Investment From 4DMedical And Signs Global Distribution Agreement For RevealAI-Lung - Pulse 2.0
RevealDx secured a $3.4 million investment from 4DMedical and a global distribution agreement for RevealAI-Lung, its AI-powered lung nodule characterization software. 4DMedical will distribute the software across the US, Europe, Australia, and New Zealand.
2026-08
4DMedical
AI Lung Cancer Risk Assessment Meets Functional Lung Imaging Through New 4DMedical-RevealDx Partnership
4DMedical announced a distribution agreement and strategic investment in RevealDx, integrating RevealAI-Lung into its cardiopulmonary imaging ecosystem. RevealAI-Lung uses AI to characterize pulmonary nodules and generate a Malignancy Similarity Index (mSI), complementing 4DMedical's functional imaging.
2026-08

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Frequently Asked Questions

RevealAI-Lung is designed to integrate directly into your Picture Archiving and Communication System (PACS), allowing for a seamless workflow. With a single click on a lung nodule in a CT scan, the software computes a Malignancy Similarity Index (mSI) score within seconds. This score provides additional information to assist radiologists in making more informed follow-up recommendations and can lead to earlier cancer diagnoses and potentially reduce unnecessary procedures.
RevealAI-Lung has received FDA clearance in the US and MDR certification in Europe, as well as approvals from the TGA in Australia and Health Canada. The software has been validated on over 1,500 patients from various cohorts. Studies have shown that the mSI score can significantly improve nodule classification and has the potential to identify up to 45% of malignant nodules earlier, reducing delayed cancer diagnoses.
Yes, other companies offer AI-powered lung nodule screening tools, such as Median Technologies' eyonis software and Qure.ai's qCT LN Quant. RevealAI-Lung differentiates itself by providing a Malignancy Similarity Index (mSI) score, which has been shown to significantly improve radiologist performance and reduce false positives. It also emphasizes direct integration into PACS for improved workflow.
In the US, RevealAI-Lung is reimbursable under the Medicare Outpatient Prospective Payment System (OPPS) at a rate of $650, using codes 0721T and 0722T. In Europe, it is the first radiology AI to be reimbursed, starting in Germany, due to its health economics benefits like reducing unnecessary procedures.
While RevealAI-Lung has demonstrated clinical benefits, physicians should be aware that AI tools, in general, can have limitations such as potential discordance with radiology reports and varying sensitivity for different nodule sizes. It is intended for use by radiologists for incidentally-detected pulmonary nodules of 6-15mm in patients aged 18 or above, and the user makes the final determination on patient management.

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Suggest an Edit → | Last Verified: 2026-08-19 | First Added: 2026-08-19
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