Median Technologies has announced it has received FDA 510(k) clearance for eyonis® LCS, the first AI-powered Software as a Medical Device (SaMD) cleared by the U.S. Food and Drug Administration specifically for lung cancer screening. The device uses artificial intelligence and machine learning to support the detection and diagnosis of pulmonary nodules on Low-Dose CT (LDCT) scans, a critical step in identifying lung cancer at an early, treatable stage. Lung cancer remains the leading cause of cancer-related deaths in the United States, with early detection through LDCT screening significantly improving survival rates. Patients diagnosed with stage 1 lung cancer have an 80% long-term survival rate, compared to just 15% for those diagnosed after symptoms appear. eyonis® LCS is designed to help radiologists detect suspicious nodules earlier, reduce variability between readers, and improve the efficiency and consistency of lung cancer screening programs. The device has demonstrated strong performance in manufacturer testing, achieving 93.3% sensitivity, 92.4% specificity, and a remarkable 99.9% Negative Predictive Value (NPV). This low false positive rate—just one per 1,000 scans—gives clinicians high confidence in ruling out cancer, reducing unnecessary follow-up procedures and patient anxiety. eyonis® LCS is engineered to integrate seamlessly into existing hospital imaging workflows, including Picture Archiving and Communication Systems (PACS), minimizing disruption and supporting real-time decision-making. The system helps manage rising screening volumes and addresses the growing shortage of radiologists by streamlining the diagnostic process. In the United States, approximately 14.5 million people are currently eligible for lung cancer screening based on age (50–80 years) and a 20-pack-year smoking history. This number is expected to grow as screening guidelines expand. The commercial environment is further strengthened by an established reimbursement framework: AI-driven CT tissue characterization is covered under Category III CPT codes 0721T and 0722T, part of New Technology APC 1508, with Medicare payments ranging from $601 to $700 per procedure. This predictable payment pathway supports rapid adoption by imaging providers. Median Technologies plans to launch eyonis® LCS in the U.S. through direct enterprise sales, strategic distribution partnerships, and integration into clinical settings. The company will leverage the current CMS reimbursement system while pursuing broader insurance coverage in the future. The launch follows a strong regulatory track record, with the company also advancing its European regulatory pathway and expecting CE marking by Q2 2026, which will expand access to the technology across Europe. Fredrik Brag, CEO and Founder of Median Technologies, called the FDA clearance a major milestone. He emphasized that eyonis® LCS is poised to transform lung cancer care by enabling earlier, more accurate diagnosis and helping healthcare systems scale screening efforts. He also highlighted the company’s broader mission to expand AI-driven cancer detection to other indications, including liver, pancreatic, colon, and prostate cancers—always with the goal of catching cancer at a curable stage. Median Technologies, a French-based innovator in AI-powered medical imaging, develops eyonis® and iCRO, tools used in oncology clinical trials and patient diagnostics. The company operates in the U.S., Europe, and China and is listed on Euronext Growth under ticker ALMDT.