Neel AcharySeattle, WA – Feb 04: RevealDx, a leader in artificial intelligence solutions for lung nodule characterization, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for RevealAI-Lung, its AI-powered lung nodule risk assessment software. The announcement follows the company’s MDR Certification, received in November 2025.
RevealAI-Lung is designed to assist radiologists in the evaluation of incidental lung nodules by generating a Malignancy Similarity Index (mSI™)—a clinically relevant score that supports more informed follow-up recommendations and aids in earlier and more accurate cancer diagnosis. The technology has been validated on data from more than 1,500 patients across diverse clinical cohorts.
The RevealAI-Lung CADx device offers several differentiated capabilities, including:
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Significant improvement in radiologist reader performance (AUC delta)
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Use of real-world National Lung Screening Trial (NLST) data as the reference population
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Clinically meaningful malignancy risk scoring
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Industry-first direct integration into PACS, enabling seamless workflow integration
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Strong generalizability across exam types and patient populations
RevealAI-Lung is available for purchase directly from RevealDx or through its U.S. distributor, Sirona. The company has also announced integrations with Riverain, the leading lung nodule detection company in the U.S., as well as FUJIFILM PACS, further expanding clinical accessibility.
With FDA clearance, RevealAI-Lung is now eligible for Medicare reimbursement under CPT codes 0721T and 0722T, supporting broader clinical adoption.
Commenting on the milestone, Chris Wood, CEO of RevealDx, said,
“We are excited to announce that RevealAI-Lung is now available in the United States. We would like to thank our clinical collaborators for their invaluable support in achieving this milestone. Most importantly, we are enthusiastic about the positive impact RevealAI-Lung can have on patient care by enabling more confident and timely clinical decision-making.”
