Median Technologies, manufacturer of eyonis, has announced eyonis LCS has obtained CE marking as a Class IIb medical device, under the new European Medical Device Regulation (MDR 2017/745), enabling commercialisation 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.
Across the EU, an estimated 25 to 30 million individualsmay 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.
At the same time, major countries including France are advancing large-scale pilot initiatives designed to assess the feasibility of organised lung cancer screening in real-world settings. In France, the national IMPULSION study has been launched as a large-scale pilot program to evaluate the feasibility of implementing organised lung cancer screening using low-dose CT in a real-world setting, targeting approximately 20,000 high-risk individuals and combining screening with smoking cessation support.
Italy also stands out as one of the most advanced European countries in lung cancer screening, with a nationwide network-based approach (RISP) and multiple large-scale pilot programs already underway, providing a real-world foundation for the future expansion of organised screening.
The key growth drivers for lung cancer screening in the EU are the transition from pilot programs to national deployment, increasing pressure on radiology capacity, and the progressive integration of standardised, AI-enabled workflows, which will create a strong foundation for scalable, technology-driven solutions such as eyonis LCS.
“Receiving CE marking is a critical step in our mission to make earlier, more accurate lung cancer diagnosis accessible to more patients eligible for lung cancer screening in Europe,” said Fredrik Brag, Founder and CEO of Median Technologies.
“Several European nations have already launched lung cancer screening programs and our AI-based eyonis LCS SaMD was developed to aid earlier detection and diagnosis of lung cancer, when treatment is more likely to be successful, helping patients gain faster access to potentially life-saving therapies. The CE marking of eyonis LCS – which follows the recent FDA 510(k) clearance for the US market – positions us as a key player in Europe, well‑suited to support healthcare systems in scaling screening programs with enhanced accuracy, efficiency, and clinical confidence,” Fredrik Brag added.
