Median Technologies has received CE marking for eyonis® LCS as a Class IIb medical device under the European Medical Device Regulation (MDR 2017/745), enabling commercialization of its artificial intelligence-powered software across the European Economic Area. The certification, granted by the French notified body GMED, follows the U.S. Food and Drug Administration’s 510(k) clearance of the software in February 2026, extending access to the company’s AI-based solution for lung cancer screening.
Designed as Software as a Medical Device (SaMD), eyonis® LCS assists clinicians in detecting pulmonary nodules on low-dose CT scans and classifying them as probably benign, suspicious or very suspicious. The software is intended to support earlier lung cancer diagnosis, improve patient risk stratification and clinical management, and facilitate the broader implementation of population-based screening programs.
The approval comes as lung cancer screening initiatives continue to expand across Europe. Median estimates that between 25 million and 30 million individuals across the European Union could qualify for screening under current high-risk criteria. National screening programs are already operating in countries including England, Poland and Croatia, while Germany launched a nationwide program in April 2026. France and Italy are also advancing large-scale pilot initiatives aimed at supporting wider implementation of organized screening.
“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.
Brag added, “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.”
According to the company, eyonis® LCS combines computer-aided detection (CADe) and computer-aided diagnosis (CADx) within low-dose CT screening workflows. Manufacturer performance data indicate 93.3% sensitivity and 92.4% specificity, alongside reported reductions of 68% in false positives and 66% in false negatives compared with unaided radiologist interpretation. Median said these capabilities could help reduce unnecessary follow-up procedures while supporting earlier and more confident identification of lung cancer as European screening programs continue to expand.
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