eyonis LCS is the only device capable of both detecting and characterizing lung cancer in low-dose CT scans, with 93.3% sensitivity, 92.4% specificity, and 99.9% Negative Predictive Value
Median Technologies, a global leader in AI-powered medical imaging and early cancer detection solutions, announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its eyonis LCS software. This innovative tool, powered by artificial intelligence and machine learning, is the first computer-aided detection and diagnosis system specifically designed to support lung cancer screening programs. Lung cancer remains the leading cause of cancer deaths in the United States, and outcomes are significantly improved when the disease is identified at an early stage. Low-Dose CT screening can detect stage one lung cancer when curative treatment is possible, resulting in approximately 80 percent long-term survival compared with roughly 15 percent five-year survival for cases identified after symptoms appear.
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eyonis LCS assists clinicians by analyzing Low-Dose CT scans to detect and characterize pulmonary nodules. It helps reduce variability among radiologists, supports earlier detection of suspicious lesions, and enhances the efficiency and consistency of lung cancer screening efforts across healthcare systems. Fredrik Brag, CEO and Founder of Median Technologies, said the FDA clearance represents a major milestone for the company and a critical step in expanding access to AI-assisted lung cancer screening in the U.S. He added that eyonis LCS is designed to support clinical teams in managing growing screening volumes and provide high-accuracy, timely diagnosis for patients, potentially saving hundreds of thousands of lives over time. Brag also emphasized that the technology will serve as a foundation for expanding AI applications into additional cancers such as liver, pancreatic, colon, and prostate cancer, all with the goal of detecting disease at stages where treatment is most effective. In performance testing using a reference population, eyonis LCS demonstrated 93.3 percent sensitivity, 92.4 percent specificity, and a 99.9 percent negative predictive value, minimizing false positives and providing clinicians with strong confidence in diagnosis. The system integrates seamlessly into hospital imaging workflows, including PACS, enabling radiologists to maintain high-quality screening while reducing routine workload. With approximately 14.5 million people eligible for lung cancer screening in the United States and a reimbursement framework already in place through CPT Category III codes, eyonis® LCS is positioned for rapid adoption.
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Median plans to deploy the solution through direct enterprise sales, strategic partnerships, and integration into existing clinical environments, while also pursuing long-term insurance coverage expansion. The company continues to advance regulatory approval in Europe and expects CE marking in the second quarter of 2026, further broadening access to this life-saving technology.
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