SOPHIA ANTIPOLIS, France, July 2, 2026
Median Technologies has announced that its eyonis® LCS, an artificial intelligence (AI)-powered Software as a Medical Device (SaMD) for lung cancer screening, has received CE Marking as a Class IIb medical device under the European Medical Device Regulation (MDR 2017/745). The regulatory milestone follows the product’s U.S. FDA 510(k) clearance earlier this year and enables the commercial launch of eyonis® LCS across the European Economic Area (EEA). Designed to support clinicians during low-dose computed tomography (LDCT) lung cancer screening, the AI solution combines computer-aided detection (CADe) and computer-aided diagnosis (CADx) to identify pulmonary nodules, classify cancer risk, and improve early lung cancer diagnosis. As European countries continue expanding national lung cancer screening initiatives, the CE Mark positions Median Technologies to deliver advanced AI-powered diagnostic solutions capable of improving screening accuracy, reducing diagnostic uncertainty, and supporting earlier patient intervention.
AI-Powered Software Enhances Lung Cancer Detection
eyonis® LCS has been developed to address one of the greatest challenges in modern lung cancer screening—accurately identifying suspicious pulmonary nodules while minimizing unnecessary follow-up procedures. Unlike conventional AI tools that focus solely on either nodule detection or diagnosis, eyonis® LCS uniquely combines CADe and CADx capabilities within a single integrated screening workflow. The software analyzes LDCT scans, detects lung parenchymal nodules, and classifies them as probably benign, suspicious, or very suspicious, helping clinicians make faster and more informed diagnostic decisions.
According to Median Technologies, manufacturer validation demonstrated 93.3% sensitivity and 92.4% specificity, significantly outperforming conventional unaided radiologist interpretation. The AI platform also demonstrated a 68% reduction in false-positive findings and a 66% reduction in false-negative diagnoses, reducing unnecessary invasive procedures while improving early identification of lung cancers. These performance improvements have the potential to enhance patient management, increase radiology efficiency, and improve confidence in lung cancer screening programs.
European Screening Programs Drive Commercial Expansion
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The CE Mark enables immediate commercialization of eyonis® LCS across the European Union at a time when lung cancer screening programs are rapidly expanding. Several countries, including England, Poland, Croatia, and Germany, have already implemented or launched national screening initiatives, while additional large-scale pilot programs continue to advance throughout Europe. Millions of individuals considered at high risk for lung cancer are expected to become eligible for LDCT-based screening, creating substantial demand for AI-assisted diagnostic technologies capable of supporting increasing imaging workloads.
Median Technologies believes its AI solution will help healthcare systems manage rising screening volumes while improving diagnostic consistency and clinical workflow efficiency. By reducing false-positive and false-negative findings, the platform also has the potential to decrease unnecessary diagnostic procedures, lower healthcare costs, reduce patient anxiety, and enable earlier treatment for individuals diagnosed with lung cancer at more curable stages.
Regulatory Milestone Strengthens AI Diagnostics Leadership
The successful CE Mark certification, following FDA clearance, represents another major achievement for Median Technologies as it expands its global leadership in AI-powered medical imaging and Software as a Medical Device (SaMD). The company’s eyonis® portfolio combines advanced artificial intelligence, machine learning, and medical image analysis to improve cancer detection while supporting oncologists, radiologists, and healthcare providers with clinically validated decision-support tools. As healthcare systems increasingly integrate AI-enabled diagnostic workflows, technologies capable of improving early detection and reducing diagnostic variability are becoming essential components of precision oncology.
With lung cancer remaining one of the leading causes of cancer-related mortality worldwide, the commercial availability of eyonis® LCS across Europe provides clinicians with an innovative technology designed to enhance screening accuracy, optimize clinical decision-making, and improve patient outcomes through earlier diagnosis. The latest regulatory achievement reinforces Median Technologies’ commitment to advancing AI-driven healthcare solutions that support scalable, efficient, and evidence-based cancer screening programs worldwide.
Source: Median Technologies press release
