Implantable Device Continuously Monitors Brain Activity in Epileptic Patients

Epilepsy is one of the most prevalent and serious chronic neurological disorders, impacting around 52 million people globally. It is characterized by recurrent seizures, which are caused by abnormal electrical activity in the brain. Seizures can manifest in various ways, with some involving motor symptoms such as intense muscle contractions, while others, like absence or focal impaired awareness seizures, may have subtle or no visible signs. The frequency of seizures varies from patient to patient, ranging from fewer than one per year to multiple episodes per day. Without accurate diagnosis and monitoring, managing epilepsy effectively over the long term can be difficult. To address the limitations of current electroencephalogram (EEG) technologies, a novel implantable device enables continuous brain activity monitoring in epilepsy patients.

Epiminder (Melbourne, Australia) has created the Minder, a proprietary implantable continuous electroencephalogram monitoring system (iCEM) designed to provide enhanced diagnosis and management for individuals with epilepsy. The Minder system addresses the limitations of traditional EEG technologies, offering reliable and actionable diagnostic data that can help improve the prospects for successful treatment. By extending the monitoring period and enabling continuous EEG recording, Minder revolutionizes the patient experience, particularly in drug therapy monitoring and pre-surgical planning. Unlike traditional EEG methods that usually last from minutes to a few days, the Minder system can record continuously for up to three years, with some devices used in patients for over five years.

The system provides signal quality on par with the standard 10-20 scalp EEG but with reduced noise levels, ensuring consistent and accurate data capture. Minder also offers secure cloud-based access for healthcare providers, enabling remote care and regular clinical assessments without the need for patients to visit medical facilities. Epiminder has received FDA authorization for the Minder system via the De Novo classification, and it has also been designated as a Breakthrough Technology by the FDA, acknowledging its potential for improving diagnosis and management of epilepsy. The safety and effectiveness of Minder were validated through the UMPIRE clinical study, a multi-center, prospective, open-design, case-controlled comparator trial conducted in leading Australian hospitals between 2019 and 2023. The findings from the UMPIRE study were instrumental in supporting Epiminder's successful FDA application. Epiminder plans to officially launch the Minder system in the U.S. in the second half of 2025, with a phased rollout across leading epilepsy centers to demonstrate the system's clinical utility.

"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,” said Rohan Hoare PhD, CEO of Epiminder. “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. As the first and only implantable continuous EEG monitor approved in US, 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.”

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