CE Mark Awarded to Median Technologies’ eyonis LCS

Median Technologies’ eyonis LCS has received CE Mark authorization as a Class IIb medical device under the European Medical Device Regulation (MDR 2017/745). 

The regulatory approval marks a major achievement for eyonis LCS, the company’s AI/ML-powered Software as a Medical Device (SaMD), executives claim. eyonis LCS helps clinicians 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 clinical management, and ultimately enabling lung cancer screening program implementation at scale.

Following the eyonis LCS’s U.S. Food and Drug Administration (FDA) clearance in February, the CE marking further expands access to Median’s AI-based SaMD, which is designed to address the biggest clinical unmet needs in lung cancer screening—the false positives and false negatives that significantly hamper existing screening programs.

EU Lung Cancer Screening Programs

In the European Union, 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, as evidenced by the launch of Germany’s nationwide screening program in April. 

At the same time, major countries, including France, are advancing large-scale pilot initiatives that assess the feasibility of organized 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 organized lung cancer screening using low-dose computed tomography 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 organized screening.

The key growth drivers for EU lung cancer screening are the transition from pilot programs to national deployment, increasing pressure on radiology capacity, and the progressive integration of standardized, artificial intelligence (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,” Median Technologies Founder/CEO Fredrik Brag said. “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.” 

Ability to Find Lung Cancer Early is Critical

Lung cancer is the leading cause of cancer death in the EU, accounting for 20% of the total number of cancer deaths.² Early detection dramatically changes the prognosis of lung cancer. Data from the International Early Lung Cancer Action Program (I-ELCAP) show a 20-year survival rate of 81% for lung cancers diagnosed through annual CT screening and 92% for Stage I cancers resected within two months of diagnosis,³ compared with an estimated five-year survival rate of only 10% to 12% for metastatic lung cancer.⁴

Unlike existing AI-based solutions primarily focused on either lung nodule detection or lung cancer diagnosis outside of screening pathways, eyonis LCS is the world’s first to combine computer‑aided detection (CADe) and computer‑aided diagnosis (CADx) embedded directly within the diagnostic care pathway of LDCT lung cancer screening. 

By enabling the characterization of pulmonary parenchymal nodules during screening, Median’s SaMD can potentially reduce unnecessary downstream workups while supporting earlier and more confident cancer identification by clinicians.

As more European countries implement national lung cancer screening programs, eyonis LCS’s CE Mark authorization positions Median as a key player in Europe, well‑suited to support healthcare systems in scaling screening programs with enhanced accuracy, efficiency, and clinical confidence, according to the company.

eyonis LCS’ manufacturer values have demonstrated a 93.3% sensitivity (finding cancer when present) and 92.4% specificity (ruling out cancer when not present). By contrast, traditional lung cancer screening by unaided radiologists demonstrated 80.3% sensitivity and 76.4% specificity,⁵ positioning eyonis LCS’ performance at a significant clinical advantage.

eyonis LCS has demonstrated a 68% reduction of False Positives (FP),⁶ helping clinicians focus on the actual nodules of interest and prevent avoidable follow-up procedures, including potentially harmful invasive ones, reducing overwhelming patient anxiety, and lowering excessive workload for clinical teams amid ongoing workforce shortages.

eyonis LCS has demonstrated a 66% reduction of False Negatives (FN),⁷ avoiding missed cancers, upgrading patient management, and saving lives.

Pioneering Software as a Medical Device (SaMD) and imaging services, Median Technologies harnesses cutting-edge AI to enhance early cancer diagnosis and treatment accuracy. Median’s offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis, an AI/ML tech-based suite of SaMD. Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the United States and China, trades on the Euronext Growth market. Median is also eligible for the French SME equity savings plan scheme.

References
¹ Estimate derived from country‑level modelling extrapolated to the EU population, and consistent with published epidemiological data on smoking prevalence and high‑risk screening criteria.
² European Commission Joint Research Center – 2024 estimates of cancer cases and death in the EU, February 2026
³ Henschke CI, Yip R, et al. A 20-Year Follow-Up of Participants with Lung Cancer Diagnosed in the International Early Lung Cancer Action Program (I-ELCAP). Radiology. 2023 and International Early Lung Cancer Action Program (I-ELCAP). Research Summary.
⁴ American Cancer Society/SEER survival statistics
⁵ Jonas DE, et al. Screening for Lung Cancer with Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Task Force. JAMA. 2021 Mar 9;925(10):971-987
⁶ Estimated from Jonas DE, et al. Screening for Lung Cancer with Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Task Force. JAMA. 2021 Mar 9;925(10):971-987
⁷ Estimated from Jonas DE, et al. Screening for Lung Cancer with Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Task Force. JAMA. 2021 Mar 9;925(10):971-987