> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Clears Median’s AI Lung Cancer Screener
- URL: https://www.fdaweb.com/fda-clears-medians-ai-lung-cancer-screener/
- Published: 2026-02-09T12:00:00.000Z
- Updated: 2026-09-14T15:32:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160633

FDA has cleared a Median Technologies 510(k) for eyonis LCS, the first artificial intelligence (AI)–based device cleared for both detection and diagnosis in lung cancer screening. The software-as-a-medical-device is designed to help clinicians identify lung cancer at earlier, potentially curable stages while reducing false positives and unnecessary follow-up procedures, according to the company.

Median says the device analyzes low-dose CT (LDCT) scans to detect and characterize parenchymal pulmonary nodules. In performance testing, eyonis LCS demonstrated 93.3% sensitivity, 92.4% specificity, and a 99.9% negative predictive value, indicating a very low rate of false positives. Median Technologies says this capability could improve diagnostic confidence, reduce inter-reader variability, and streamline screening programs nationwide.

Lung cancer remains the leading cause of cancer death in the U.S., with early-stage detection dramatically improving long-term survival, the company says.