Median Technologies’ eyonis® LCS Obtains CE Marking

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SOPHIA ANTIPOLIS, France, July 03, 2026--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, "Median" or the "Company"), manufacturer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, today announced eyonis® LCS has obtained CE marking as a Class IIb medical device, under the new European Medical Device Regulation (MDR 2017/745), enabling commercialization across the European Economic Area. The CE marking, granted by the French notified body GMED demonstrates compliance with the highest European standards for patient safety and clinical efficacy. This marks a major achievement for eyonis® LCS, the Company's AI/ML-powered SaMD. eyonis® LCS helps clinicians both detect lung parenchymal nodules on LDCT scans and characterize them as probably benign, suspicious or very suspicious, thus supporting early cancer diagnosis, patient risk stratification, improved patients' clinical management, and ultimately enabling lung cancer screening programs implementation at scale. Following February 2026's clearance of eyonis® LCS by the U.S. Food and Drug Administration (FDA), the CE marking further expands access to Median's AI-based SaMD designed to address the biggest clinical unmet needs in lung cancer screening: the false positives and false negatives, which significantly hamper existing screening programs. Lung cancer screening programs across the European Union (EU) Across the EU, an estimated 25 to 30 million individuals1 may be eligible for lung cancer screening under current high‑risk criteria, representing a substantial and largely untapped addressable market for early diagnostic solutions. Lung cancer screening programs across Europe are gaining momentum. While only a limited number of countries have established national programs—such as England, Poland and Croatia—Europe is entering an acceleration phase, illustrated by the launch of Germany's nationwide screening program in April 2026.

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