Epiminder announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary implantable continuous electroencephalogram monitoring system (iCEMTM) for patients with epilepsy.  

Minder has also been designated as a Breakthrough Technology by the FDA, recognising its potential to provide more effective diagnosis and management for people living with epilepsy. This De Novo authorization is significant as it creates a new classification of device which underscores both the innovation and the clinical validation behind Minder.

Without accurate diagnosis and monitoring, sustained and effective management of epilepsy can be challenging.  Minder has been developed to address the shortcomings in current electroencephalogram (EEG) technologies, providing reliable and actionable diagnostic data for more patients and therefore better enabling their prospects for successful epilepsy treatment. 

Rohan Hoare PhD, CEO of Epiminder, 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.  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.

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."

Epiminder intends to formally launch Minder in the US during H2 2025 undertaking a phased commercial roll out into leading epilepsy centres as part of a program to demonstrate the clinical utility of the system.

Professor Robert Fisher MD, PhD, Director of the Stanford Epilepsy Center, past-President of the American Epilepsy Society, and Chair of the Data Safety Monitoring Board for the UMPIRE trial, said: "One of the greatest difficulties in caring for people with epilepsy is the lack of accurate information about a patient's seizures. Seizure diaries are of limited effectiveness. Minder can greatly improve seizure tracking and therefore seizure management. It will fill the significant gap in current EEG technologies, providing clinicians like me continuous and accurate data. By having a more complete picture, we can be more precise in our diagnoses, better able to rapidly adjust medication or neuromodulation regimens and identify patients for potential non-drug or surgical treatments. The result will be a reduction in the huge burden of drug resistant epilepsy."

The safety and effectiveness of Minder was validated through Epiminder's UMPIRE clinical study, a multi-centre prospective, open design, case-controlled comparator trial that was undertaken in leading Australian hospitals between 2019 and 2023.  The results of UMPIRE were used to support Epiminder's successful FDA application.

Professor Mark Cook MD MBBS FRACP FRCP (London), Epiminder's Founder and Chief Medical Officer, said: "The results from UMPIRE exceeded our expectations and demonstrated Minder's ability to capture high-quality EEG data continuously for extended periods, including a groundbreaking five-year continuous recording in one participant.  Minder delivered actionable clinical insights for nearly 90 percent of study participants, highlighting the real-life benefits that Epiminder's best-in-class iCEM can deliver relative to the current standard of care."