Median Technologies Secures CE Mark for its Eyonis LCS Software
Median Technologies announced on July 3 that it has obtained the CE marking for Eyonis LCS, its artificial intelligence software designed for the detection and diagnosis of lung cancer in screening programs. This European authorization follows the FDA approval in the United States in February 2026 and opens up the product's commercialization across the European Union.
A Device Combining Detection and Diagnosis
Eyonis LCS is distinguished by its ability to combine computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) directly integrated into low-dose computed tomography screening. The product assists clinicians in detecting pulmonary parenchymal nodules and characterizing them as likely benign, suspicious, or highly suspicious, enabling patient risk stratification and improved clinical management.
Performance and Reduction of False Positives and Negatives
According to Median, Eyonis LCS shows a sensitivity of 93.3% (detecting cancer when present) and a specificity of 92.4% (excluding cancer when absent), compared to 80.3% and 76.4% for traditional screening without computer assistance. The software demonstrates a 68% reduction in false positives, limiting unnecessary follow-ups and invasive procedures, and a 66% reduction in false negatives, reducing the risks of missed cancer.
An Expanding Market in Europe
According to Median, between 25 and 30 million individuals in the European Union would be eligible for lung cancer screening based on current criteria. Several European countries are accelerating their initiatives: Germany launched its national screening program in April 2026, France is rolling out the IMPULSION study targeting 20,000 high-risk individuals, while Italy continues its large-scale pilot programs. Fredrik Brag, founder and CEO of Median Technologies, stated that the CE marking positions the company as 'a key player in Europe, well-suited to support health systems in scaling up screening programs.'
