The U.S. Food and Drug Administration–approval of a novel electroencephalogram known as Minder, granted under the De Novo classification, could allow the device to be marketed among patients with drug-resistant epilepsy.

Developed by Epiminder, an Australian-based medical device firm, the novel device has also been designated a Breakthrough Technology by the U.S. Food and Drug Administration (FDA) because of its potential to support more effective epilepsy management through long-term electroencephalogram (EEG) monitoring.

According to the manufacturer, current EEG technologies are limited by short-duration recordings, which may be insufficient for capturing infrequent or subclinical seizures. Minder enables continuous EEG monitoring for extended periods—potentially months to years—while patients maintain their daily routines. According to the company and clinical advisors, Minder provides constant EEG data to aid in diagnosis, therapeutic monitoring, and evaluation of suitability for surgical or other nonpharmacologic interventions.

The FDA’s authorization was supported by the UMPIRE trial, a multicenter, prospective, open-label, case-controlled study conducted across leading Australian hospitals from 2019 to 2023. In the study, Minder produced clinically actionable data in approximately 90% of participants, including one instance of continuous 5-year recording. The findings demonstrated the novel device’s capacity to offer long-term, ambulatory EEG data of sufficient quality to inform clinical decisions.

Rohan Hoare, PhD, Chief Executive Officer of Epiminder, stated that extending the EEG monitoring window substantially improves access to clinically meaningful data for physicians and their patients. Robert Fisher, MD, PhD, Director of the Stanford Epilepsy Center and Chair of the UMPIRE data safety board, noted that Minder may address a significant clinical gap, as seizure diaries often lack reliability. He emphasized that continuous, objective EEG data can enhance treatment individualization and identify candidates for advanced interventions.

Epilepsy affects an estimated 52 million patients globally, including 3.4 million in the United States. Epiminder intends to launch Minder commercially in thecountry during the second half of 2025, beginning with selected epilepsy centers. The company is currently developing integrated software solutions to expand the clinical utility of Minder, including artificial intelligence–based seizure forecasting tools.

Source: Epiminder