Median Technologies Receives FDA 510(k) Clearance for eyonis® LCS, the First AI-Based Lung Cancer Screening Device
Median Technologies announced on February 9, 2026, that it received FDA 510(k) clearance for eyonis® LCS, the first AI-powered end-to-end detection and diagnosis device for lung cancer screening using low-dose CT scans.
eyonis® LCS achieves 93.3% sensitivity, 92.4% specificity, and 99.9% Negative Predictive Value, aiming to detect cancer early, reduce false positives, and support screening for 14.5 million eligible US individuals.
The company plans US commercialization via direct sales, partnerships, and PACS integration, leveraging existing reimbursement codes like NT-APC 1508.
CE marking is expected in Q2 2026 for Europe.
The announcement led to a surge in Median Technologies' shares.