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, releases today its 2025 key business results (including unaudited figures) and provides an outlook on its critical milestones in 2026.
Management Statement
“Median made outstanding progress in 2025 which provides the foundations to deliver significant achievements in the coming years. We have achieved key regulatory, commercial, and operational milestones, providing significant momentum for further accelerating our growth trajectory to create long term value for our shareholders and clients,” said Fredrik Brag, CEO and Founder of Median Technologies.
Thomas Bonnefont, COO and CCO of eyonis®, said: “We expect a pivotal year for eyonis® in 2026. The FDA’s decision on 510(k) clearance for eyonis® LCS is expected in the coming weeks, followed by a European decision on CE marking, which we expect in the second quarter. The U.S., where lung cancer screening is already established with 14.5 million eligible patients, is our primary commercial target. We are actively building our commercial operations, starting with a first distribution agreement in December 2025 and with more to follow. The successful pivotal studies with eyonis® LCS demonstrate its potential as the new standard-of-care in lung cancer screening both in the U.S. and in Europe, and Median is determined to deliver on that.”
Nicolas Dano, COO and CCO of iCRO, said: “Our iCRO business enters 2026 with strong momentum. With an order backlog of 76.6 million euros as of December 31, 2025 (€83.1 million at constant forex) supported by exceptional fourth-quarter booking, we expect to accelerate revenue growth in 2026. At the same time, we will continue executing the optimization of our organization, and automation of our operations to further enhance iCRO business profitability. The initiatives launched in 2024 have already delivered significant gains, positioning iCRO for sustained and profitable growth in the year ahead.”
eyonis®LCS Software as a Medical Device: AI-driven Innovation for Lung Cancer Screening
2025 Key Achievements
2025 was a major milestone for the eyonis® program, with the completion of pivotal studies for eyonis® LCS, Median’s proprietary AI-based SaMD for lung cancer screening, followed by regulatory submissions for both FDA 510(k) clearance and European CE marking, respectively in May and June 2025.
To support the U.S. launch, Median completed a comprehensive mapping of lung cancer screening channels nationwide and has a well-defined strategy to deploy its organization and operations. Median is actively implementing its plan, laying the foundation for an accelerated successful commercial launch post FDA clearance.
In December 2025, the Company signed its first non-exclusive agreement with a leading U.S. healthcare company for the distribution of eyonis® LCS in the United States and Europe. Both organizations are now collaborating to ensure strong market impact following regulatory clearance.
Median further strengthened its network of key opinion leaders across radiology, pulmonology, and thoracic oncology, increasing visibility among early adopters and advancing the design of upcoming health-economic studies. Engagement with patient advocacy groups also intensified throughout the year.
2026 Strategic Outlook and Key Milestones
eyonis® LCS remains under regulatory review in both the U.S. and Europe. The FDA’s response regarding the 510(k) submission is expected in the coming weeks, while feedback for CE marking is anticipated in Q2.
Median is engaged in advanced discussions with additional industry leaders to widen its commercial reach across the U.S., Europe and possibly Asia.
In 2026, alongside the commercial rollout of eyonis® LCS, the Company will accelerate development of additional SaMD within the eyonis® portfolio, with a focus on eyonis® IPN (Incidental Pulmonary Nodules) and eyonis® HCC (Hepatocellular Carcinoma). The expansion of this portfolio will leverage current commercial efforts and reinforce Median’s global position in early cancer diagnosis.
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