Median Technologies Gains FDA Clearance for AI Lung Cancer Tool
Median Technologies has secured FDA clearance for its eyonis LCS, an AI-powered software designed for early lung cancer detection from medical scans. The regulatory approval allows the company to begin commercialization in the United States. The clearance is a key milestone for deploying specialized AI tools in regulated healthcare markets.
- The tool, a Software as a Medical Device (SaMD), received FDA 510(k) clearance, a pathway for devices that are substantially equivalent to a legally marketed device. In its pivotal RELIVE trial, the software demonstrated a statistically significant improvement in diagnostic accuracy for radiologists (p=0.027) compared to radiologists reading scans alone. - In manufacturer performance tests, eyonis LCS showed 93.3% sensitivity, 92.4% specificity, and a 99.9% Negative Predictive Value, which indicates a very low rate of false positives (1 per 1,000). This aims to reduce unnecessary follow-up procedures for patients. - The global AI lung screening system market was valued at $307 million in 2025 and is projected to reach $725 million by 2034, growing at a 13.2% CAGR. Key competitors in the broader AI cancer diagnostics space include Lunit, Aidoc, Riverain Technologies, Paige AI, and Tempus. - To lead the U.S. commercialization, Median has appointed Oran Muduroglu as President of its U.S. subsidiary. Muduroglu has a track record of scaling and exiting medical imaging companies, including co-founding Stentor (acquired by Philips) and serving as CEO of Medicalis (acquired by Siemens Healthineers). - Median's go-to-market strategy includes direct enterprise sales and distribution partnerships. The company has already signed a non-exclusive distribution agreement with Tempus AI to integrate eyonis LCS into Tempus's Pixel platform. - The company anticipates its first U.S. clinical sites will be operational in the third quarter of 2026. The software is eligible for reimbursement under existing Medicare codes, with payments ranging from approximately $601 to $700 per exam in 2026. - Based in France, Median Technologies trades on the Euronext Growth market (ALMDT); its stock price surged over 44% after the FDA clearance announcement. The company expects to receive CE marking for European market access in the second quarter of 2026. - Early diagnosis of lung cancer is critical; when detected at early stages, the five-year survival rate can be around 80%, compared to approximately 15% for cases detected later due to symptoms. An estimated 14.5 million Americans are eligible for lung cancer screening.
