FDA OKs Minder Implantable Continuous EEG Monitor for Epilepsy

Epiminder has been granted U.S. Food and Drug Administration (FDA) de novo authorization for Minder, its implantable continuous electroencephalogram monitoring system (iCEM) for epilepsy patients. Minder was also awarded breakthrough designation from the FDA.

Minder was developed to address the shortcomings in today’s electroencephalogram (EEG) technologies. It provides reliable, actionable diagnostic data for more patients, better enabling prospects for successful epilepsy treatment.

The company plans to launch Minder in the U.S. in the second half of 2025 with a phased commercial rollout into leading epilepsy centers.

“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 Epiminder CEO Rohan Hoare, Ph.D. “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,” Dr. Hoare went on.

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

“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,” said Professor Mark Cook MD MBBS FRACP FRCP (London), Epiminder’s founder and chief medical officer. “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.”