RevealDx, a Seattle-based medical imaging company specializing in artificial intelligence (AI) for lung nodule characterization, announced today that it has received clearance from the US Food and Drug Administration (FDA) for its software, RevealAI-Lung.
The clearance paves the way for technology’s commercial availability in the US, building on the company’s previous MDR certification in Europe announced in November 2025.
How the AI-Powered Technology Works
RevealAI-Lung is designed as a Computer-Aided Diagnosis (CADx) device intended to assist radiologists in evaluating incidental lung nodules. The core of the technology is its generation of a Malignancy Similarity Index (mSI), a quantitative score that characterizes a detected nodule. By providing this risk assessment, the software aims to support clinicians in making more informed and consistent follow-up recommendations, potentially leading to earlier cancer diagnosis.
The company states the software has been validated on data from over 1,500 patients across diverse cohorts, underscoring its potential generalizability. The clinical foundation for RevealAI-Lung is supported by research conducted by RevealDx and its collaborators. The company has previously published studies demonstrating the technology’s ability to improve early cancer detection rates while simultaneously reducing false positives.
Key Features and Workflow Integration
According to the company’s announcement, RevealAI-Lung includes several notable features designed for clinical utility. A key highlight is its claim of a significant improvement in radiologist performance, as measured by the area under the curve (AUC), a common metric for diagnostic accuracy. The software utilizes real-world data from the National Lung Screening Trial (NLST) as a reference population for its scoring.
For clinical workflow, a major differentiator is its ability to integrate directly into a Picture Archiving and Communication System (PACS). The company notes this is a first for this type of technology, aiming to minimize disruption to radiologists’ existing routines. The system is designed to be generalizable across different exam types and patient populations.
RevealAI-Lung will be available for purchase directly from RevealDx or through its US distributor, Sirona. The company has also previously announced integrations with US-based Riverain and Fujifilm’s PACS.
A critical component of the US launch is the assignment of Medicare reimbursement. With this FDA clearance, the software is now eligible for reimbursement by Medicare using Category III CPT codes 0721T and 0722T, a significant step for clinical adoption
