RevealDX has obtained US Food and Drug Administration (FDA) clearance for RevealAI-Lung, an artificial intelligence (AI)-based software for lung nodule risk assessment.

The Washington-based company’s Computer-Assisted Diagnostic (CADx) software is designed to analyse chest CT scans for lung nodules and assess their risk of malignancy. In characterising lung nodules, the software assigns them with a Malignancy Similarity Index (mSI), a score that is intended to assist radiologists in making more informed follow-up recommendations to assist in cancer diagnosis.

Following certification under the European Union’s Medical Device Regulation (EU MDR) in November 2025, with FDA clearance in hand, RevealAI-Lung is now reimbursable in the US under the Medicare Outpatient Prospective Payment System (OPPS) at a rate of $650.