UNEEG Medical Announces FDA 510(k) Clearance for UNEEG EpiSight System

Copenhagen, Denmark, June 15, 2026 – UNEEG Medical today announced that its subcutaneous EEG monitoring system (UNEEG EpiSight System) has obtained 510(k) clearance from the FDA, marking a major milestone in the company’s mission to transform epilepsy care through continuous, real world brain monitoring and actionable insights.

The UNEEG EpiSight System is designed to enable ultra long term (24/7) electroencephalography (EEG) monitoring in real world settings. The minimally invasive implant, placed just beneath the skin, captures continuous brain activity data over extended periods and has been clinically validated to deliver high quality, longitudinal EEG data. Combined with advanced analytics, this supports improved seizure tracking, enables clinicians to objectively identify seizure activity, and helps optimize clinical decision making and therapy for patients living with epilepsy.

“Receiving FDA clearance is a significant step forward in bringing continuous, real world EEG monitoring to patients and clinicians in the United States” said Martin Stenfeldt, CEO of UNEEG Medical. “We believe that better data leads to better decisions. By moving beyond isolated clinical snapshots, our solution enables deeper insights into patients’ everyday lives and supports more personalized and effective treatment. As a further advantage, this is the first subcutaneous EEG system that allows patients to undergo MRI scans under specific conditions (1.5T or 3T) without requiring removal of the device.”

Epilepsy affects millions of people worldwide, and management of the condition is often challenged by limited or inconsistent data. UNEEG’s technology addresses this gap by enabling continuous monitoring, offering a more comprehensive understanding of brain activity as patients go about their daily lives.

“This clearance reinforces our position as a leader in next generation EEG monitoring. The EpiSight System is the first longitudinal EEG system to be both FDA cleared and approved according to MDR in Europe” added Martin Stenfeldt. “We are focused on working closely with clinicians, researchers, and pharma/medtech partners to improve outcomes for people living with epilepsy and to advance the broader field of brain health.”

Following this milestone, UNEEG Medical is preparing for U.S. commercialization and continued expansion of its clinical and research collaborations.