Median Technologies Secures FDA Clearance for AI-Powered Lung Cancer Screening Tool

Median Technologies has achieved a significant milestone with its AI-powered lung cancer screening device, eyonis® LCS, receiving FDA 510(k) clearance. This innovative tool aims to transform lung cancer screening by enabling early and accurate diagnoses, potentially saving countless lives. Designed to cater to the 14.5 million individuals eligible for screening in the U.S., this advancement promises to enhance current healthcare practices.

Lung cancer remains the deadliest cancer in the United States, where early detection is crucial for improving survival rates. The eyonis® LCS system tackles this challenge by combining AI and machine learning to identify and evaluate pulmonary nodules on low-dose CT scans. With a promising sensitivity of 93.3%, specificity of 92.4%, and a near-perfect Negative Predictive Value of 99.9%, the device sets new standards in accuracy and efficiency. The FDA clearance not only marks an industry first but also paves a clear path for its widespread adoption, supported by an existing reimbursement code, NT-APC 1508.

Fredrik Brag, CEO of Median Technologies, believes eyonis® LCS could be a game-changer, supporting healthcare professionals in diagnosing lung cancer early. As the company looks to scale deployment across the U.S., this development positions them at the forefront of AI-driven cancer diagnostics. The clearance is also a stepping stone for Median’s plans to expand their AI applications into other cancer types, broadening the horizon for cancer care advancements.