Imaging software developer Median Technologies has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its eyonis LCS, an AI-based detection and diagnosis software as a medical device (SaMD) for lung cancer screening.
The software identifies and characterizes lung cancer on low-dose CT scans, with 93.3% sensitivity, 92.4% specificity, and 99.9% negative predictive value, and a false positive rate of one per 1,000 exams, according to the firm. It can be integrated into healthcare systems' PACS, it said.
Median will provide further details regarding the commercial launch of eyonis LCS in the coming weeks and plans to continue along the European Union regulatory pathway toward CE marking.
