Epitel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its REMI Remote EEG Monitoring System for Ambulatory (at home) use and REMI Vigilenz AI For Event Detection.

These technologies are designed to help neurologists in the detection and analysis of suspected seizure events in patients within home healthcare settings over extended periods.

REMI for Ambulatory is designed to allow EEG recording for extended periods in outpatient and home environments.

REMI Vigilenz AI for Event Detection aids in the interpretation of EEG records by marking potential electrographic seizures.

Epitel CEO and co-founder Mark Lehmkuhle said: “Existing EEG monitoring systems have been cumbersome and restrictive for patients, and technical requirements and limitations have impeded providers' ability to administer, record, and interpret EEG. REMI Ambulatory and REMI Vigilenz AI For Event Detection will help patients and providers make better-informed treatment decisions.

“We are excited about how these two advances will shift the paradigm of brain health monitoring.”

REMI Ambulatory uses REMI Sensors, to provide extended-duration EEG to capture crucial data over weeks or months. This is vital for accurate seizure assessment.

Featuring advanced machine learning, the REMI Vigilenz AI for Event Detection annotate potential seizure events in EEG records, categorising them with varying confidence levels to streamline interpretation.

The FDA has also approved a Predetermined Change Control Plan for REMI Vigilenz AI, allowing for ongoing training and performance enhancement in seizure detection, which is expected to improve clinical care.

Epitel plans to launch these technologies through select practices later in the year.

In 2022, Epitel secured $12.5m in Series A funding for the development and commercialisation of the REMI EEG monitoring system for detecting seizures.