RevealDx has earned U.S. Food and Drug Administration clearance for RevealAI-Lung, an artificial intelligence-powered tool for detecting malignant lung nodules. The clearance transpires roughly three months after the tool gained MDR Certification.

The RevealDx technology characterizes incidental lung nodules by producing a Malignancy Similarity Index (mSI), a score intended to help radiologists make more informed follow-up recommendations to assist in cancer diagnosis. The company has validated the software on more than 1,500 patients from a various 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
• Generalization ability across exam types and patient populations

The software can be purchased directly from RevealDx or through the company’s U.S. distributor, Sirona. The company previously announced it has integrated with Riverain, a U.S. lung nodule detection company 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 U.S.,” RevealDx CEO Chris Wood said. “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.”

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.