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.
![Axial images from unenhanced calcium score cardiac CT (left) and curved planar reformation images from CT angiography (right) show that higher long-term exposure to air pollution is associated with greater coronary artery calcium and more obstructive coronary artery disease (CAD). Top row: Images in a 68-year-old male patient with higher 10-year mean ambient air pollution exposure (7.9 μg/m3 for particulate matter measuring ≤2.5 μm in diameter [PM2.5] and 17.4 parts per billion [ppb] for NO2) with extensive CAD (coronary artery calcium score [CACS] >1,000 and obstructive CAD [≥70% diameter stenosis]). Bottom row: Images in a 57-year-old female patient with lower 10-year mean ambient air pollution exposure (6.3 μg/m3 for PM2.5 and 4.6 ppb for NO2) with no CAD (CACS = 0 and no obstructive stenosis).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/06/hanneman.r6SMLzkezo.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
