RevealAI-Lung
AI-powered lung nodule risk assessment software for non-invasive cancer diagnosis
Company profile
Company profile
RevealDx is a Seattle-based medical imaging software company whose mission is to dramatically improve lung cancer outcomes through non-invasive diagnosis. The company has developed RevealAI-Lung, an FDA-cleared, AI-powered decision support tool that characterizes incidental lung nodules found on chest CT scans. Using proprietary radiomics and ensemble AI techniques, RevealDx produces a Malignancy Similarity Index (mSI) score that helps clinicians assess cancer risk and make more informed treatment decisions. The technology employs a patented approach that provides improved stability across image types and allows for transparency of predictions. It extracts local predictive value from three-dimensional analysis of lesions, then enhances results using broader lung and chest analysis. Ensemble classification techniques are coupled with layers of radiomic features to provide depth of analysis, converging more quickly on accurate predictive values than CNNs alone. RevealAI-Lung integrates directly with PACS systems via single-click operation, displaying results within seconds. The solution aims to reduce unnecessary procedures, lower healthcare costs, and enable earlier cancer detection. RevealDx has validated its software on over 1,500 patients from various cohorts and the product is now reimbursable by Medicare using CPT codes 0721T and 0722T. The company serves radiologists, health systems, and healthcare providers focused on improving lung nodule management workflows.
Company description Precision Medical Ventures, Inc. Dba Revealdx official website
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01 · Operating footprint
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On Premise deployment with recorded integration context.
Recorded integration context: PACS systems.
Company milestones
FDA clearance received February 2026. CE Mark (MDR) certification received November 2025. Partnership with Azra AI announced May 2026. Medicare reimbursement codes established (0721T and 0722T).
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02 · Flagship portfolio
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AI-powered lung nodule risk assessment software for non-invasive cancer diagnosis
03 · Research intelligence
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Research
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Clinical validation
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Regulatory
K251769 · 510k · Jan 30, 2026
04 · Company-reported outcomes
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Multiple published studies
Clinical validation studies
Cost savings through better nodule triage
When mSI included in assessment
Clinical validation of RevealAI-Lung for lung nodule risk assessment
Demonstrated clinical benefit for lung nodules
05 · Leadership
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06 · Company updates
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08 · Official presence
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09 · Market pathway
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Market context
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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