FDA Clearance Granted for Median Technologies' AI-based Lung Cancer Device

Median Technologies has announced that its AI-powered software, eyonis® LCS, has received FDA 510(k) clearance. The device is designed to enhance lung cancer screening by supporting diagnosis at early stages, while minimizing false positives to avoid unnecessary follow-ups. It is the first device of its kind to detect and characterize lung cancer in low-dose CT scans, boasting a sensitivity of 93.3% and specificity of 92.4%.

This clearance paves the way for widespread deployment of lung cancer screening programs across the U.S., where 14.5 million individuals are eligible for such screening. The established NT-APC 1508 code ensures a reliable reimbursement pathway, promoting rapid adoption.

Median Technologies aims to leverage this opportunity to enhance patient outcomes by integrating eyonis® LCS into existing healthcare systems, reducing workload, and supporting earlier identification of lung cancer.