Minder, the iCEM system, could provide more effective diagnosis and management for people living with epilepsy. The technology also received FDA breakthrough device designation, according to a news release.
Australia-based Epiminder designed Minder to address the shortcomings in current electroencephalogram (EEG) technologies. It aims to provide reliable, actionable diagnostic data for more patients to enhance epilepsy treatment and management.
CEO Rohan Hoare says the system extends the monitoring window of EEG from days to months or even years. This could deliver “unprecedented access” to continuous EEG data for both healthcare professionals and their patients.
Epiminder plans to formally launch the Minder system during the second half of 2025. It expects to begin with a phased commercial rollout to leading epilepsy centers as part of a program to demonstrate the system’s clinical utility.
“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,” Hoare said. “As the first and only implantable continuous EEG monitor approved in U.S., Minder can provide health care professionals and their patients with more accurate and timely diagnoses, enhanced therapeutic drug monitoring, and can better inform decisions on non-drug treatments like surgery.
“Looking ahead, Epiminder plans to develop a suite of integrated software solutions that will extend the clinical impact of the Minder device, for example by providing patients with advance notice of seizures through AI-enabled forecasting.”
