Cebreo Medical Receives CE Mark for NeuroBuds®, a Discreet In-Ear, Medical-Grade EEG Wearable for Extended Ambulatory Monitoring

Cebreo Medical Receives CE Mark for NeuroBuds®, a Discreet In-Ear, Medical-Grade EEG Wearable for Extended Ambulatory Monitoring

The Danish medtech company's ear-EEG platform can now be placed on the European market, enabling clinicians to record multi-day and multi-night EEG in the patient's home for epilepsy, sleep and other neurophysiological research and care.

Cebreo Medical today announced that its NeuroBuds® device has received CE marking, confirming conformity with applicable EU requirements. Unlike conventional EEG systems that require a technician-applied cap of electrodes, NeuroBuds is designed to be used unassisted by the patient at home, enabling multi-day and multi-night recordings in a patient's daily life environment.

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NeuroBuds(TM), EarEEG

“With NeuroBuds, we can offer a discreet, unobtrusive solution that enables long-term, unassisted EEG monitoring for weeks, in patients’ own homes. The product has the potential to significantly reduce the cost of long-term EEG monitoring and strengthen treatment decisions compared with conventional brain monitoring.”
— Rasmus Madsen, CEO, Cebreo Medical

Designed to resemble a hearing aid, NeuroBuds is built to minimize the stigma and burden that typically limit compliance in long-term EEG monitoring. Because it is comfortable and simple enough for unassisted use, it supports monitoring periods of up to three months, with repeat measurements.

Extending EEG monitoring beyond the hospital

Extended, ambulatory EEG monitoring has relevance well beyond a single condition — from epilepsy to sleep medicine and other areas of neurophysiological research. Drug-resistant epilepsy is one clear example: treatment decisions depend on an accurate, longitudinal picture of seizure frequency and treatment response.

“For patients with drug-resistant epilepsy, the question is not whether they have seizures — it's how often, and whether a new treatment is actually working. Patient-reported seizure counts are often unreliable, particularly for subtle or nocturnal seizures patients don't even notice. An ambulatory ear-EEG device that can run for weeks at a time, in the patient's own daily life, provides the EEG data with the potential to objectively quantify the seizure burden, and hence, more properly evaluate treatment.”
— Prof. Sandor Beniczky, Department of Clinical Neurophysiology, Rigshospitalet; Danish Epilepsy Centre

What's next

With CE marking secured, Cebreo Medical will expand commercial availability across European research and clinical sites while advancing its US regulatory pathway.

About Cebreo Medical

Cebreo Medical A/S is a Danish medical technology company developing wearable EEG solutions for extended, real-world neurophysiological monitoring.

Jacob Thang Nielsen
jani@cebreomedical.com
+45 22620769

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