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.
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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.
RevealDX CEO Chris Wood commented: “We are excited to announce that RevealAI-Lung will now be available in the US.
“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.”
RevealAI-Lung has been validated on over 1,500 patients from a variety of cohorts. In a retrospective case-control study with the department of radiology at the Royal United Hospitals Bath UK National Health Service (NHS) Foundation Trust, the software’s production of an mSI upgraded 44% of 45 cases, thereby reducing delayed cancer diagnoses from 45% to 25%.
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By GlobalDataGiven these results, the study concluded that mSI significantly improved nodule classification in incidental lung nodules when combined with current best practice guidelines from the British Thoracic Society (BTS).
Medical imaging has emerged as a key area in which AI is demonstrating its value in the healthcare space. According to GlobalData analysis, AI in healthcare is projected to reach a $19bn valuation by 2027.
Other companies with lung nodule screening tools include Median Technologies’ AI-powered eyonis software as a medical device (SaMD) for the characterisation of cancerous lung nodules, and Qure.ai.
Similar to RevealDX’s offering, Qure.ai gained FDA clearance for its AI-powered chest CT solution, qCT LN Quant, in August 2024. Results from a study of Qure.ai’s tool, conducted at Bangkok’s Phrapokklao Hospital’s Cancer Centre of Excellence and presented at the World Conference on Lung Cancer in September 2024, revealed that the Indian company’s tool was able to detect the early symptoms of lung cancer up to three years before symptoms presented themselves.
