Median Technologies, manufacturer of eyonis, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, announced the signing of a non-exclusive global commercial distribution agreement with a leading US healthcare company.
The agreement covers the future commercialisation of eyonis LCS, Median’s AI-based SaMD for lung cancer.
The collaboration will leverage the commercial partner’s robust infrastructure and broad market reach in both the U.S. and Europe to ensure efficient distribution of eyonis LCS, once regulatory clearances are granted in the U.S., then in Europe.
Both companies will collaborate closely in a structured and coordinated manner to ensure a strong impact following 510(k) clearance. The commercial phase of this collaboration is expected to begin once Median Technologies will have obtained 510(k) clearance for eyonis LCS from the US FDA, which is anticipated in early Q1 2026. eyonis LCS is currently under review for FDA 510(k) clearance and CE marking and is not yet for sale in the US and in Europe.
Fredrik Brag, CEO and Founder of Median Technologies said: “This strategic, non-exclusive collaboration with a recognised healthcare leader, will position us for a successful commercial rollout of our eyonis LCS Software as a Medical Device and long-term impact.
“This agreement, which comes as we approach key regulatory milestones with upcoming decisions on approval in the U.S. and Europe, strengthens our ability to accelerate the deployment of lung cancer screening. It also enhances our capacity to further improve patient outcomes, by supporting public health initiatives aimed at reducing lung cancer mortality through screening.”
