Median Technologies' AI tool wins EU nod for earlier lung cancer detection

Median Technologies' AI‑powered eyonis® LCS software has received CE marking under the EU Medical Device Regulation (MDR 2017/745), enabling commercialization across the European Economic Area for lung cancer screening.

eyonis® LCS is the first AI‑based Software as a Medical Device (SaMD) to combine both computer‑aided detection (CADe) and computer‑aided diagnosis (CADx) within low‑dose CT lung cancer screening programs.

According to manufacturer data, eyonis® LCS achieves 93.3% sensitivity and 92.4% specificity, outperforming traditional unaided radiologist screening, which reported 80.3% sensitivity and 76.4% specificity.

The tool analyzes low‑dose CT scans to detect lung parenchymal nodules and classify them as probably benign, suspicious, or very suspicious, helping radiologists stratify patient risk and implement screening programs at scale.

After receiving FDA 510(k) clearance in early 2026, the CE mark positions eyonis® LCS for broader global rollout and integration into national lung cancer screening initiatives in Europe.