Median Technologies Secures Key Certification for its AI Oncology Software
Median Technologies announces the acquisition of the international ISO 13485:2016 certification for its Quality Management System applicable to medical device software based on artificial intelligence. This certification, issued by the accredited notified body GMED, covers all activities of the eyonis® operational unit.
Validation of Industrialization and Large-Scale Deployment
The ISO 13485:2016 certification validates Median Technologies' ability to industrialize and deploy on a large scale its eyonis® portfolio, including the design, development, deployment, sales, and maintenance of AI-based medical device software. This certification is part of a compliance cycle initiated in 2025, which has already resulted in the acquisition of ISO 27001:2022 and HDS 2.0 certifications. These certifications demonstrate the robustness and high quality of the company's quality management system, as well as its ability to handle sensitive data.
A Major Step Towards Future Regulatory Approvals
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Median Technologies describes this certification as major in view of future regulatory approvals for its eyonis® portfolio, particularly the expected CE marking in the second quarter of 2026 for eyonis® LCS. The company emphasizes that this certification strengthens its preparation and ability to provide safe, reliable, and clinically relevant oncology solutions, meeting the stringent requirements of healthcare professionals and international regulatory authorities. This validation follows the FDA's 510(k) authorization for eyonis® LCS in February 2026 and the commercial launch in the United States.
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Context
Period
Period: 1S2026
Key reported figures
Revenue: 11.8M€
Guidance from the release
Median a renforcé sa position grâce à l'augmentation de capital.
Performance solide avec un fort carnet de commandes.
Risks mentioned
Risques de fluctuations de demande dans l'industrie biopharmaceutique.
Réglementations changeantes pouvant impacter la commercialization.
Concurrence accrue sur le marché des dispositifs médicaux.
Opportunities identified
Lancement commercial d'eyonis® LCS aux États-Unis.
Partenariat stratégique avec Tempus AI en cours.
Croissance continue de l'activité iCRO avec des niveaux de carnet de commandes record.
The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.
Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.
