Median Technologies to Highlight eyonis® LCS at ECR 2026 as U.S. Commercial Launch Advances and European CE Marking Decision Nears
Median Technologies today announced that it will showcase its AI-powered lung cancer screening solution, eyonis® LCS, at the upcoming European Congress of Radiology (ECR) 2026, taking place in Vienna, Austria, from March 4–6, 2026. The announcement comes at a pivotal time for the company, as commercial rollout of eyonis® LCS is now underway in the United States following recent FDA clearance, while the CE-marking regulatory review process continues in Europe with a decision anticipated in the second quarter of 2026.
Median Technologies is the developer of eyonis®, a comprehensive suite of artificial intelligence (AI)-powered Software as Medical Devices (SaMDs) designed to support early cancer diagnosis. The company is also widely recognized as a global leader in AI-driven image analysis and central imaging services for oncology drug development. At ECR 2026, Median will spotlight the clinical value and technological capabilities of eyonis® Lung Cancer Screening (LCS), its end-to-end AI/ML-based CADe/CADx medical device software solution.
U.S. Commercial Launch Following FDA 510(k) Clearance
Earlier this month, Median Technologies achieved a major regulatory milestone when eyonis® LCS received FDA 510(k) clearance. The clearance authorizes the software for detection and characterization of parenchymal pulmonary nodules in low-dose CT (LDCT) scans, a critical component of modern lung cancer screening programs.
The U.S. commercial launch of eyonis® LCS is currently ongoing, marking a significant step in bringing AI-driven lung cancer detection tools into clinical practice. The software is designed to assist clinicians in identifying suspicious pulmonary nodules at earlier stages, with the goal of improving patient outcomes through earlier diagnosis and timely intervention.
According to manufacturer-reported performance data calculated on a lung cancer screening reference population, eyonis® LCS demonstrated:
- 93.3% sensitivity
- 92.4% specificity
- 99.9% negative predictive value (NPV)
These metrics underscore the software’s strong ability to both detect and accurately characterize lung nodules while minimizing false negatives. By combining computer-aided detection (CADe) and computer-aided diagnosis (CADx) into a single, integrated platform, eyonis® LCS provides a comprehensive solution for radiologists evaluating LDCT scans.
European Regulatory Progress and Anticipated CE Marking
In parallel with its U.S. expansion, Median Technologies continues to progress along the European regulatory pathway. The CE-marking process for eyonis® LCS is currently ongoing, with a regulatory decision expected in Q2 2026. If granted, CE marking would enable the commercial rollout of the software across Europe later this year.
Thomas Bonnefont, Chief Operating Officer and Chief Commercial Officer of the eyonis® Business Unit at Median Technologies, emphasized the importance of this moment for the company:
“Earlier this month, Median Technologies received FDA 510(k) clearance for eyonis® LCS, marking a pivotal milestone in our mission to transform lung cancer screening through cutting-edge AI innovation. As we work toward the obtention of our CE marking for eyonis® LCS, with a decision expected in Q2 this year, we are preparing for the next step: bringing our technology into clinical practice across Europe and empowering clinicians with new tools to diagnose lung cancer earlier and more effectively.”
The anticipated CE marking would position eyonis® LCS as a Class IIb end-to-end Medical Device Software (MDSW) solution under European regulatory standards, reinforcing its clinical robustness and compliance with stringent safety and performance requirements.
Presence at ECR 2026: Booth and Technical Exhibition
At ECR 2026, the Median eyonis® team will welcome attendees at Booth #AI-16, located within the AI Exhibition at Expo X1. The technical exhibition will run from March 4 through March 7, providing an opportunity for radiologists, researchers, healthcare executives, and industry stakeholders to explore the latest developments in AI-enabled imaging technologies.
At the booth, the company will present detailed demonstrations of eyonis® LCS, highlighting:
- Its AI-driven detection and characterization capabilities
- Clinical workflow integration features
- Performance validation data
- Potential impact on lung cancer screening efficiency and consistency
The software is specifically designed to support radiologists in assessing pulmonary parenchymal nodules identified in LDCT scans. By combining detection and risk characterization into one streamlined system, eyonis® LCS aims to reduce variability, improve diagnostic confidence, and enhance screening program effectiveness.
Bonnefont further noted:
“We are thrilled to showcase our innovative software as a medical device, eyonis® LCS—a Class IIb end-to-end Medical Device Software—to the European radiology community gathered in Vienna for ECR. eyonis® LCS is designed to assist radiologists in the detection and characterization of pulmonary parenchymal nodules and represents a significant leap forward in lung cancer screening.”
Featured Presentations at ECR 2026
Beyond its exhibition presence, Median Technologies will actively contribute to the scientific and industry dialogue at ECR through multiple presentations, including two AI Lightning Talk industry sessions and one research-focused session.
Industry Presentation 1
Title: “eyonis® LCS: redefining Lung Cancer Screening with AI”
Presenter: Stefania Baraghini, VP Marketing eyonis® – Median Technologies
Session: AI-IND 3 – AI Lightning Talks 3
Date & Time: Wednesday, March 4 – 13:30–14:30 CET
Location: AI Theatre, ACV Building Level -2
This session will focus on how eyonis® LCS leverages artificial intelligence to enhance detection accuracy and clinical workflow efficiency in lung cancer screening programs.
Industry Presentation 2
Title: “eyonis® LCS: Transforming Lung Cancer Screening through AI-powered detection & diagnosis”
Presenters:
- Stefania Baraghini, VP Marketing eyonis®
- Laurence Boy-Machefer, VP Regulatory Affairs eyonis®
Session: AI-IND 8 – AI Lightning Talks 8
Date & Time: Thursday, March 5 – 16:00–17:00 CET
Location: AI Theatre, ACV Building Level -2
This presentation will examine the regulatory journey, clinical validation, and real-world application of AI-powered detection and diagnostic tools in lung cancer screening.
Research Presentation
Title: “AI-Assistance Improving Lung Nodule Risk Assessment in Lung Cancer Screening: Results from RELIVE, A Multi-Reader Multi-Case Study to Evaluate the Performance of an End-to-End AI/ML-based CADe/CADx”
Presenter: Charles Voyton, Associate Director Clinical Development – eyonis®
Session: RPS 105 – Exploring the AI-radiomics interface in lung cancer
Category: Artificial Intelligence and Imaging Informatics
Date & Time: Wednesday, March 4 – 08:00–09:30 CET
Location: ACV Research Stage 6, Vienna, Austria
The RELIVE study presentation will share results from a multi-reader, multi-case evaluation designed to assess the performance of eyonis® LCS in improving lung nodule risk assessment. The research session will provide insights into how AI assistance can support radiologists in interpreting LDCT scans and optimizing screening outcomes.
Advancing Early Cancer Detection Through AI
Lung cancer remains one of the leading causes of cancer-related mortality worldwide, largely due to late-stage diagnosis. Low-dose CT screening programs have demonstrated significant benefits in reducing mortality, but their effectiveness depends heavily on accurate detection and consistent interpretation of pulmonary nodules.
eyonis® LCS is engineered to address these challenges by integrating advanced AI and machine learning algorithms into a clinically deployable software platform. By offering both detection (CADe) and diagnostic characterization (CADx) capabilities, the solution aims to streamline the screening pathway from image acquisition to risk stratification.
With its U.S. commercial launch underway and European regulatory approval potentially imminent, Median Technologies is positioning eyonis® LCS as a transformative tool in lung cancer screening. The company’s participation at ECR 2026 marks an important opportunity to engage directly with the global radiology community and demonstrate how AI-powered medical device software can support earlier, more reliable lung cancer diagnosis.
As regulatory progress continues and commercialization expands, Median Technologies remains focused on its broader mission: leveraging artificial intelligence to enable earlier cancer detection and improve patient outcomes worldwide.
About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median’s offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis®, an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME).
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