RevealDX has received U.S. 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-aided diagnostics (CADx) software is designed to analyze lung nodules in chest CT scans and assess the risk of malignancy. When evaluating the characteristics of a lung nodule, the software assigns a malignant similarity index (mSI) to the lung nodule. This score is intended to help radiologists make more informed follow-up recommendations to aid in cancer diagnosis.
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Having received certification under the European Union Medical Device Regulation (EU MDR) in November 2025 and clearance from the FDA, RevealAI-Lung is now reimbursable in the United States under the Medicare Ambulatory Prospective Payment System (OPPS) at a fee of $650.
Chris Wood, CEO of RevealDX commented:
“We would like to thank our clinical collaborators for helping us achieve this milestone and look forward to having the software up and running in the first facility in the first quarter.”
RevealAI-Lung has been validated in over 1,500 patients across various cohorts. In a retrospective case-control study with the Department of Radiology at the Royal United Hospitals Bath NHS Foundation Trust, software generation of mSI improved 44% of 45 cases, thereby reducing delays in cancer diagnosis from 45% to 25%.
Considering these results, this study concluded that mSI, when combined with the British Thoracic Society (BTS) current best practice guidelines, significantly improves nodule classification in incidental pulmonary nodules.
Medical imaging has emerged as a key area where AI is demonstrating its value in healthcare. According to a GlobalData analysis, the valuation of AI in healthcare is expected to reach $19 billion by 2027.
Other companies offering lung nodule screening tools include Median Technologies’ AI-powered eyonis software as a medical device for characterization of cancerous lung nodules (SaMD) and Qure.ai.
Similar to RevealDX’s products, Qure.ai received FDA clearance in August 2024 for qCT LN Quant, an AI-powered chest CT solution. A study of the Qure.ai tool conducted at the Cancer Center of Excellence at Prapoklao Hospital in Bangkok and presented at the World Congress on Lung Cancer in September 2024 revealed that the Indian company’s tool can detect up to three early symptoms of lung cancer. years before symptoms appear.
