UNEEG Medical marks first pediatric implantation in Europe-led study
COPENHAGEN, January 8, 2026 – UNEEG Medical is proud to announce a groundbreaking milestone: for the first time, a child has been included in a clinical study using UNEEG’s ultra long-term brain monitoring solution. This achievement marks a crucial step toward regulatory approval for pediatric use in Europe and underscores the importance of early treatment for children with epilepsy.
First Implantation in Children
In December 2025, a 13-year-old child was implanted with UNEEG’s minimally invasive subcutaneous EEG device at Ospedale Pediatrico Bambino Gesù, IRCCS, in Rome, Italy. The child experiences daily epileptic seizures and mild cognitive impairment, making accurate seizure reporting difficult. Using UNEEG’s technology, clinicians aim to objectively measure seizure burden and assess treatment impact following immune globulin therapy. The procedure was led by site investigator Professor Nicola Specchio: “This technology allows us to objectively measure seizure frequency over extended periods, which is critical for tailoring treatment in complex pediatric cases,” he says.
About the EMIRE Study
The implantation is part of EMIRE (EEG Monitoring In Rare Epilepsies), an investigator-initiated, off-label multicenter clinical trial led by Professor Stefano Meletti, University of Modena and Reggio Emilia. The study was funded by the European Union (Next Generation EU, PNRR Italy) and involves four advanced epilepsy centers in Modena, Trieste, Naples, and Rome, focusing on drug-resistant rare epilepsies. Its goal is to evaluate feasibility, safety, and clinical impact of home-based ultra long-term EEG monitoring using UNEEG’s subcutaneous EEG device. ”By reducing reliance on inaccurate self-reporting and hospitalization, we aim to enable personalized treatment strategies and improve management of severe epilepsies”, Professor Stefano Meletti says, “Including children in this study is a major step toward improving care for rare epilepsies.”
Currently approved for adults, UNEEG’s solution is being evaluated for pediatric use in this study, which plans to include seven children under 18 years of age. The off-label use in this clinical study has been approved by the Italian Medicines Agency. Upon completion, the trial will provide the first pool of pediatric data and valuable insights for future regulatory approval. “Our solution makes it possible to estimate the real seizure burden and measure treatment impact. This study is the first step toward being part of diagnostics and treatment of epilepsy in children,” says Martin Stenfeldt, CEO of UNEEG Medical. “We are grateful to the exceptional team at Ospedale Pediatrico Bambino Gesù and our dedicated UNEEG team for making this milestone possible.”
Why It Matters
Epilepsy in children presents unique challenges. Conventional EEG methods rely on short hospital-based recordings and subjective diaries, which often fail to capture real-life seizure patterns. UNEEG’s subcutaneous EEG technology offers continuous, ultra long-term monitoring during daily life, providing objective, high-quality data for months or years. This innovation supports precise treatment evaluation and improved clinical decision-making, paving the way for better pediatric epilepsy care.