FDA grants Breakthrough approval for Epiminder’s Implantable EEG System for epilepsy monitoring

FDA approves epilepsy device: ©Drmicrobe - stock.adobe.com

In a move forward for epilepsy care, the U.S. Food and Drug Administration has granted De Novo classification and Breakthrough Device designation to Minder, an implantable continuous electroencephalogram monitoring system (iCEM) developed by Australian medical device company Epiminder. The approval marks the first time an implantable, long-term EEG monitoring device has been authorized for use in the United States.

Minder is designed to continuously monitor brain activity in patients with epilepsy for months or even years—far surpassing the capabilities of current EEG technologies that typically record only a few days of data. This advancement has the potential to significantly improve diagnosis and management for the approximately 3.4 million Americans and 52 million people worldwide living with epilepsy.

“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.

Epiminder’s FDA application was supported by data from the UMPIRE clinical trial, conducted in leading Australian hospitals between 2019 and 2023. The trial demonstrated Minder’s ability to continuously record high-quality EEG data, including one patient whose device recorded continuously for five years. Nearly 90% of participants received actionable clinical insights from the device.

Mark Cook, Epiminder's founder and chief medical officer, said the trial “exceeded our expectations,” adding that Minder delivers “real-life benefits that Epiminder’s best-in-class iCEM can deliver relative to the current standard of care.”

Clinicians are already expressing enthusiasm for the technology. “One of the greatest difficulties in caring for people with epilepsy is the lack of accurate information about a patient's seizures,” said Robert Fisher, MD, PhD, Director of the Stanford Epilepsy Center. “Seizure diaries are of limited effectiveness. Minder can greatly improve seizure tracking and therefore seizure management.”

Fisher, who chaired the UMPIRE trial’s Data Safety Monitoring Board, added that the continuous and accurate data from Minder will allow clinicians to make more precise diagnoses, adjust treatments more effectively, and better identify patients for surgical options—helping to reduce the burden of drug-resistant epilepsy.

With FDA approval secured, Epiminder plans to launch Minder in the U.S. in the second half of 2025, starting with a phased rollout at leading epilepsy centers. The company also aims to build a suite of software tools, including AI-powered forecasting, to help predict seizures before they occur.

Epilepsy is a chronic neurological condition characterized by recurrent seizures caused by abnormal electrical activity in the brain. Seizure presentation and frequency vary widely, making accurate monitoring essential for treatment success.

Understanding epilepsy and emerging advances in treatment

Epilepsy is one of the most prevalent serious neurological disorders globally, affecting an estimated 52 million people, including 3.4 million in the United States and 250,000 in Australia. The condition is characterized by recurrent seizures—sudden surges of electrical activity in the brain—which can manifest in a wide range of ways. Seizures may include convulsions, loss of consciousness, behavioral disturbances, or subtle symptoms like brief lapses in awareness. For many patients, seizures are unpredictable, making daily life uncertain and often dangerous.

Despite decades of research, about one-third of people with epilepsy continue to experience seizures despite taking medication—this is known as drug-resistant epilepsy. For these individuals, accurate diagnosis and ongoing monitoring are crucial to identifying alternative treatment strategies, including surgical intervention, neuromodulation, or ketogenic dietary therapy.

Recent years have seen several promising advances in epilepsy treatment. New anti-seizure medications continue to be developed with more targeted mechanisms and improved side-effect profiles. In parallel, neuromodulation therapies such as vagus nerve stimulation (VNS), responsive neurostimulation (RNS), and deep brain stimulation (DBS) have shown efficacy in reducing seizure frequency in drug-resistant cases.

Additionally, the integration of artificial intelligence and wearable or implantable technology is transforming how epilepsy is monitored and managed. Devices like Minder represent a major leap forward by enabling continuous brain monitoring, providing data that can improve diagnosis, track treatment effectiveness, and eventually help forecast seizures before they occur.