Median Technologies has announced that its AI-powered software, eyonis® LCS, has obtained CE marking as a Class IIb medical device. Granted by the French notified body GMED, this certification confirms compliance with European standards for patient safety and clinical efficacy, allowing the company to commercially launch the device across the European Economic Area.
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The software utilizes artificial intelligence and machine learning to help clinicians detect lung nodules on low-dose CT scans and categorize them by their likelihood of being benign or suspicious. By addressing the prominent clinical challenges of false positives and false negatives, the technology aims to improve early cancer diagnosis, risk stratification, and patient clinical management.
This European approval follows the software’s U.S. FDA 510(k) clearance achieved in February 2026. The timing coincides with an acceleration of lung cancer screening initiatives across Europe, where an estimated 25 to 30 million individuals meet high-risk eligibility criteria. As nations transition from pilot projects to national rollouts—such as Germany’s nationwide screening program launched in April 2026—the software is positioned to support healthcare systems facing increased pressure on radiology capacity.
