Median Technologies has achieved a significant milestone with the CE marking of its eyonis LCS, a Class IIb medical device, under the new European Medical Device Regulation (MDR 2017/745). This certification, awarded by GMED, attests to the device's compliance with stringent European standards regarding patient safety and clinical effectiveness, enabling its commercialization across the European Economic Area.
eyonis LCS leverages artificial intelligence and machine learning to assist clinicians in detecting lung parenchymal nodules on low-dose CT scans and categorizing them based on their likelihood of malignancy. This functionality is crucial for early cancer detection, risk stratification, and improving overall patient management, thereby facilitating the implementation of widespread lung cancer screening programs.
The CE marking complements the earlier FDA clearance obtained in February 2026, broadening access to this innovative solution that addresses critical issues in lung cancer screening, particularly the challenges posed by false positives and negatives. With an estimated 25 to 30 million individuals in the EU potentially eligible for screening, eyonis LCS is positioned to tap into a significant market need.
As lung cancer screening initiatives gain traction in Europe, with countries like England and Poland already establishing programs, the landscape is evolving. Notably, Germany is set to launch its nationwide screening effort in April 2026, while France is conducting the IMPULSION study to evaluate organized screening's real-world feasibility. With Italy also advancing its screening initiatives, the momentum for AI-enhanced solutions like eyonis LCS is on the rise, promising improved accuracy and efficiency in lung cancer diagnosis.