RevealDx Receives FDA Clearance for AI

RevealDx Receives FDA Clearance for AI, Powered Lung Nodule Risk Assessment

Seattle, WA – February 3, 2026 – RevealDx, a leader in AI tools for the characterization of lung nodules, announced FDA clearance of RevealAI-Lung. The company had previously announced MDR Certification in November of 2025.

The RevealDx technology characterizes incidental lung nodules by producing a Malignancy Similarity Index (mSI™), a score that is intended to help radiologists make more informed follow-up recommendations to assist in cancer diagnosis. The company has validated the software on over 1,500 patients from a variety of cohorts.

The RevealAI-Lung CADx device has several features, including:

● Significant improvement in Radiologist reader AUC delta

● Use of real world NLST data as our reference population

● Clinically relevant malignancy scoring

● First ever integration directly into PACS, vastly improving workflow

● Generalizability across exam types and patient populations

The software can be purchased directly from RevealDx or through the company’s US distributor, Sirona. The company previously announced it has integrated with Riverain, the leading lung nodule detection company in the US, as well as Fuji PACS. With this FDA clearance, RevealAI-Lung is now reimbursable by Medicare using codes 0721T and 0722T.

“We are excited to announce that RevealAI-Lung will now be available in the US” said Chris Wood, CEO of RevealDx. “We would like to thank our clinical collaborators for their help in achieving this milestone. We are most excited about the anticipated positive impact on patient care that will result from the use of RevealAI-Lung.”

About RevealDx

RevealDx has developed RevealAI-Lung, the first Medical Imaging AI software to achieve reimbursement in Europe. The company has published several studies demonstrating significant improvement in both early cancer detection as well as reduction in false positives. Studies show that by integrating this patented technology into routine clinical use, healthcare providers can more effectively triage lung nodules. For more information, contact sales@reveal-dx.com. RevealAI-Lung is distributed in the EU by contextflow.