The US Food and Drug Administration (FDA) has approved Epiminder’s Minder, an implantable electroencephalogram (EEG) monitoring system, under the De Novo classification process.
Minder is now the only device of its kind authorised for continuous brain activity monitoring in patients with epilepsy, said Epiminder. This regulatory approval establishes a new device category in the US medical landscape and follows its designation by the FDA as a breakthrough device.
According to Epiminder, Minder has been designed to offer long-term EEG data capture, enabling clinicians to monitor brain activity outside hospital settings.
Unlike standard EEG methods that collect short-term readings, this implantable system operates continuously for up to three years. The system has already been in use in selected patients for more than five years.
Minder delivers signal quality on par with 10-20 scalp EEG systems, while operating with reduced interference.
Epiminder said that healthcare professionals can access recorded data remotely via a cloud-based system. This facilitates continuous observation and decision-making without requiring patients to attend physical appointments.
The device is intended for use during patients’ daily activities, providing uninterrupted monitoring that assists in evaluating treatment responses and guiding clinical intervention.
Epiminder CEO Rohan Hoare said: “By extending the monitoring window of an EEG from days using current technologies to months or even years with Minder, we can deliver unprecedented access to a high-fidelity stream of continuous EEG data to health care professionals and their patients.
“The FDA’s clearance of Minder is a significant milestone for Epiminder and more importantly for the 52 million people around the world who have epilepsy.”
The company has announced plans to commence commercial deployment of Minder in the US during the second half of 2025.
The launch will be phased, with initial focus on specialised epilepsy treatment centres. Epiminder is also developing supporting digital tools that will accompany the device, including features for seizure prediction powered by artificial intelligence (AI).
The clinical validation of Minder was based on findings from the UMPIRE study, a multi-centre, open-label comparator trial conducted in Australian hospitals between 2019 and 2023. This prospective research assessed the system’s performance and contributed data to support the FDA submission.
