Core Insights - The FDA has approved Median Technologies' eyonis, an AI-based lung cancer detection tool, enhancing early cancer diagnosis capabilities [1][4]. Company Overview - Median Technologies is a French medtech company specializing in AI-driven software for medical diagnostics, particularly in lung cancer screening [2]. - The company has a market capitalization of €156 million [3]. Product Details - Eyonis lung cancer screening (LCS) is a computer-aided detection and diagnosis (CADe/CADx) software designed to analyze CT scan imaging data to assist radiologists in identifying and characterizing pulmonary nodules [2]. - The software demonstrated a sensitivity of 93.3%, specificity of 92.4%, and a 99.9% Negative Predictive Value (NPV) in performance testing [4]. Market Impact - Following the FDA approval announcement, Median's stock price surged by 19% to €5.10 ($6.06) at market open, and by 15:00 CET, it had increased by approximately 50% [3]. - The company plans to roll out eyonis LCS in the US through direct sales, strategic partnerships, and integration into existing clinical environments [5]. Financial Aspects - The software is expected to be reimbursed under the current US Medicare framework at a rate between $601 to $700, with plans for broader insurance coverage in the future [6]. - In January 2025, Median received a €37.5 million grant from the European Investment Bank and €10 million from IRIS Capital Investment to support its FDA filing and future European CE mark acquisition, expected in Q2 2026 [7]. Competitive Landscape - Median's FDA clearance follows a similar approval for RevealDX's lung nodule evaluation tool, indicating a growing market for AI-based diagnostic solutions in lung cancer [8].