RevealDx Gets FDA Clearance for RevealAI-Lung

Feb. 3, 2026 — RevealDx, a leader in the characterization of lung nodules, recently announced FDA clearance of RevealAI-Lung. The company had previously announced MDR certification in November of 2025.

The RevealDX technology characterizes nodules by producing a Malignancy Similarity Index (mSI), a score that helps 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. 

This clearance marks significant milestones for Lung Nodule CADx, including: 

• Unprecedented improvement in AUC delta 
• Use of real world NLST data as our reference population 
• The most clinically relevant malignancy scoring ever developed 
• First ever integration directly into PACS, vastly improving workflow 
• Industry leading generalizability across exam types and patient populations 

The software can be purchased directly from RevealDx or through its US distributor, Sirona. The company previously announced it has integrated with Riverain, the leading nodule detection company in the US, as well as Fuji PACS. With this FDA clearance, RevealAI-Lung is now reimbursable using codes 0721T and 0722T. 

“We are excited to announce that RevealAI-Lung will now be available in the U.S.,” said Chris Wood, CEO of RevealDx. “We would like to thank our clinical collaborators for their help in achieving this milestone, and expect our first sites to go live with the software in the first quarter. We are most excited about the positive impact on patient care that will result from the use of RevealAI-Lung.”