Minder becomes first approved long-term iEEG system in U.S.
Australia-based Epiminder has received FDA de novo authorization for its Minder system, the first and only implantable continuous EEG monitor cleared in the U.S. for epilepsy management.
Key Highlights:
- Minder enables months to years of continuous brain monitoring, extending well beyond traditional EEG systems.
- The system previously earned FDA Breakthrough Device Designation.
- Targets more accurate diagnosis, optimized drug monitoring, and AI-enabled seizure forecasting.
- Commercial launch is slated for late 2025, beginning with epilepsy centers in a phased rollout.
CEO Rohan Hoare emphasized Minder’s ability to revolutionize epilepsy care by offering unprecedented access to long-term brain activity data, potentially improving outcomes for millions worldwide.
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