Epiminder Wins FDA Clearance for Implantable EEG Monitor

By

Disclaimer: Images on MEDWIRE.AI are AI-generated for illustrative purposes and are not affiliated with, endorsed by, or representative of any specific company, product, or technology.

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.

Follow MEDWIRE.AI for neurotech breakthroughs and epilepsy care innovations.