CE Marking Process Underway for Micro-Macro Electrodes (MME)

The Journey to CE Approval: Bringing MME Innovation to Europe. We are excited to announce that on November 13, DIXI medical officially submitted the necessary documentation to begin the CE marking process for our Micro-Macro electrodes (MME). This represents a significant breakthrough in our efforts to provide clinicians with the most advanced tools for intracranial monitoring. What are Micro-Macro Electrodes?. Micro-Macro electrodes are designed to bridge the gap between clinical monitoring and research. By combining standard macro-contacts (for clinical SEEG) with specialized micro-contacts (for high-resolution research recording), these electrodes allow for:. Simultaneous Clinical & Research Data: Record standard seizure activity alongside microscopic cellular-level signals., Enhanced Mapping: Better localization of the epileptogenic zone using high-definition neural data., Streamlined Workflow: A single implantation provides comprehensive data, reducing the need for separate research-only probes. Timeline and Next Steps. Following the submission, we anticipate:. 2026: Receipt of initial feedback from regulatory bodies., End of 2026: Final CE mark approval and full market availability in Europe. Prepare Your Center. As we move toward final approval, we encourage clinical centers interested in integrating MME technology into their workflow to reach out. We are committed to supporting our community through every development of this regulatory journey.