Medical technology innovator Median Technologies has officially secured the European CE marking for its advanced eyonis LCS platform today. The French notified body GMED granted the certification under the stringent European Medical Device Regulation standards. Consequently, this key regulatory milestone enables the commercial launch of the Class IIb medical device across the entire European Economic Area. This certification will significantly accelerate regional AI lung cancer screening growth.
The software is an AI-powered Medical Device Software as a Medical Device. Eyonis LCS specifically helps clinicians to identify lung parenchymal nodules in low-dose CT scans. It also classifies these nodules as benign, suspicious or highly-suspicious. This automated deep analysis enables early cancer diagnosis, patient risk stratification, and scalable clinical workflows.
Expanding Beyond United States FDA Clearance
This European milestone follows the tool’s recent United States Food and Drug Administration clearance in February 2026. Therefore, the new authorization vastly expands global access to Median’s advanced healthcare technology. The system explicitly addresses the largest unmet clinical needs in standard screening protocols. It successfully targets high false-positive and false-negative rates that typically hamper existing hospital screening infrastructure.
“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.
Targeting a Massive European Healthcare Market
Currently, up to 30 million individuals across the European Union meet the high-risk criteria for lung cancer screening. This large demographic represents a massive, untapped market for modern diagnostic solutions. Furthermore, national screening initiatives are rapidly gaining momentum across the continent. Germany recently launched a nationwide program in April 2026, while France is scaling its regional IMPULSION study. Italy also remains highly advanced, utilizing its established RISP network framework.
Unlike older software tools that focus solely on simple nodule detection, Eyonis LCS uniquely combines computer-aided detection with computer-aided diagnosis. Clinical data show the system operates at a stellar 93.3% sensitivity and 92.4% specificity. This performance completely outclasses traditional unaided radiology metrics. Most importantly, the platform cuts false positives by 68% and false negatives by 66%. This dual capability reduces unnecessary diagnostic procedures and saves lives, guaranteeing robust AI lung cancer screening growth.
Explore Health Tech Insiders for the latest medical innovations and reliable strategic insights driving the future of technology-driven healthcare transformation.
News Source: Businesswire.com
