Median Technologies announced outstanding performance of its iBiopsy LCS AI/ML tech-based end-to-end CADe/CADx Software as Medical Device, intended to enable early detection and characterization of lung cancer nodules and improve clinical management of patients. Median's iBiopsy® LCS SaMD offers a unique end-to-end detection/diagnosis approach (CADe/CADx) based on AI/ML technologies. Median aims at drastically improving the ability to detect and characterize lung cancers at their earliest stages, enabling a better patient care while avoiding unnecessary medical tests and procedures, and reducing healthcare costs.

No product is currently approved for both lung cancer detection and diagnosis in the US or Europe. With this breakthrough innovation, Median's iBiopsy® LCS SaMD brings a unique AI-powered solution for clinicians to fight lung cancer, the deadliest cancer worldwide. The study was based on a cohort of 1,760 patients from the National Lung Screening Trial (NLST) consisting of a total of 16,789 lung nodules.

The training set was composed of a subset of 1,289 patients with 12,108 nodules and the test set represented 471 patients with a total of 4,681 nodules. The performance of iBiopsy® LCS CADe/CADx SaMD to detect and characterize lung cancer nodules achieves an AUC of 0.976 and an outstanding sensitivity of 94.7% for a specificity of 93.3%.