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RevealDx Receives MDR Certification for AI Powered Lung Nodule Decision Support

November 3, 2025

RevealDx MDR Announcement FINAL.docx

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FDA, CE Mark, TGA and Health Canada have provided market authorization for clinical use in their respective jurisdictions, and RevealAI-Lung is also registered for use in the UK and New Zealand. The product is not approved for clinical use in any other jurisdiction and the content herein is for informational purposes only. This product is covered by U.S. Patent No. 10,255,997.