This clearance granted by the Food & Drug Administration is faster and less costly, relying on evidence that the new device is as safe and effective as an already widely marketed device.

According to Fredrik Brag, Chairman, CEO, and founder of Median Technologies: "The FDA 510(k) clearance for eyonis LCS represents a major milestone for Median Technologies and a key step toward expanding access to AI-assisted lung cancer screening in the United States. eyonis LCS is the first end-to-end medical device software for detection and diagnosis specifically authorized by the FDA for lung cancer screening. We are confident that eyonis LCS will be a significant advancement for medical teams facing increased screening volumes and will help healthcare systems deliver accurate and rapid lung cancer diagnoses for eligible patients."

Meanwhile, investment bank Stifel believes this clearance opens access to a total addressable market of $10 billion in the United States, targeting 14.5 million eligible individuals. Additionally, analysts also view the FDA 510(k) clearance positively, as it significantly reduces investment risk. Another positive point for Stifel: "Beyond lung cancer, proof-of-concept in hepatocellular carcinoma (HCC) indicates a strong strategy for platform expansion, ahead of the expected European CE marking catalyst in Q2 2026."

Returning to lung cancer screening, Stifel analysts forecast screening volumes of 41,000 in 2026 (10 million euros in revenue), rising to 250,000 by 2030, with revenues of 63.7 million euros and further upside potential. The American investment bank has confirmed its buy recommendation for Median Technologies shares, with a price target of 6 euros.