Epiminder Receives FDA Approval for First-of-its-Kind Minder® System

Epiminder has received De Novo authorisation from the US Food and Drug Administration (FDA) for its implantable continuous electroencephalogram (EEG) monitoring system, Minder. The FDA has also designated Minder as a Breakthrough Device, recognising its potential to significantly improve how epilepsy is diagnosed and managed.

The De Novo approval establishes a new category for medical devices, highlighting both the technological advancement and strong clinical backing behind Minder. Designed for people living with epilepsy, the device addresses current limitations in EEG technologies by offering more reliable and long-term monitoring data.

The safety and effectiveness of Minder were confirmed through Epiminder’s UMPIRE clinical study, conducted in top Australian hospitals from 2019 to 2023. This multi-centre trial showed that Minder consistently captured high-quality EEG data and delivered meaningful clinical information in nearly 90% of cases. One participant achieved a five-year continuous EEG recording—marking a first in epilepsy research.

Minder is the first and only implantable continuous EEG device to be approved in the US. It is expected to improve diagnostic accuracy, support better medication management, and provide more timely insights for both clinicians and patients. These benefits are especially relevant for individuals with drug-resistant epilepsy, who often face greater challenges in treatment planning.

Minder offers a promising step forward in helping both patients and clinicians manage epilepsy more effectively through continuous, high-fidelity brain monitoring.