FDA Grants Authorisation for Minder®, the First and Only Implantable Continuous EEG Monitor Approved in US

•  The Australian-developed Minder system is an implantable device for continuous monitoring of brain activity in patients with epilepsy, developed to address the shortcomings in current electroencephalogram technologies
•  The FDA has granted authorisation for Minder under its De Novo pathway creating a new classification of device, allowing for marketing and sale of the device in the US for patients with drug resistant epilepsy
•  Epiminder intends to launch Minder in the US during H2 2025

MELBOURNE, Australia and DALLAS, April 23, 2025 /PRNewswire/ -- Epiminder, a pioneering medical device and information solutions company, today announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary implantable continuous electroencephalogram monitoring system (iCEM^TM) 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."

Epilepsy is one of the most common serious chronic neurological disorders, affecting approximately 52 million people worldwide including 250,000 Australians and 3.4 million Americans. It is a neurological condition where a person experiences recurrent seizures caused by abnormal electrical activity in the brain.  Seizures can present with a variety of clinical manifestations; some involve motor symptoms, such as intense muscle contractions, while others, such as absence or focal impaired awareness seizures, may present with subtle or no outward physical signs.  The occurrence of seizures varies in frequency among patients, from less than one a year to several a day.

Follow Epiminder on LinkedIn and explore www.epiminder.com for more information.

About Minder

Minder is a minimally invasive device for continuous monitoring of electrographic activity of the brain, providing epilepsy patients and their doctors with detailed data on brain activity over an extended period. Patients can wear the device as they go about their normal daily activities.

Minder's long-term monitoring of patients outside of a controlled clinical environment provides data needed for better understanding and more effective treatment of underlying conditions, including determining the effectiveness of drug therapies and other potential interventions.

About Epiminder

Founded in 2017 by Professor Mark Cook together with the Bionics Institute, St Vincent's Hospital, the University of Melbourne and Cochlear Limited. Epiminder is a medical device and information solutions company focused on developing diagnostic and treatment tools for epilepsy and other seizure disorders where continuous monitoring is required. Epiminder is headquartered in Melbourne, Australia and has offices in the United States.

Contact: Matt Wright, matt@nwrcommunications.com.au