Brain health solutions developer Epitel has received the US Food and Drug Administration (FDA) 510(k) clearances for REMI Remote EEG Monitoring System for Ambulatory (at home) use and REMI Vigilenz AI For Event Detection.
REMI for Ambulatory is designed for prolonged electroencephalogram (EEG) recording in outpatient and home settings.
It uses single-use, single-patient, disposable, wearable sensors to amplify, capture, and wirelessly send a single channel of the brain’s electrical activity for up to one month.
According to the US-based Epitel, REMI Ambulatory enables prolonged EEG monitoring within the comfort of the patient’s home, while accommodating daily activities.
Supported by a mobile computing platform, REMI Ambulatory uses the familiar REMI Sensors employed in REMI for Healthcare Facility Use. The platform empowers patients and caregivers to mark occurrences or suspected events.
On the other hand, REMI Vigilenz AI for Event Detection examines and marks REMI EEG data for possible electrographic seizures. This facilitates the interpretation of the data with improved convenience and accuracy.
The system is designed to use advanced proprietary machine learning technology to detect and label potential seizure events within REMI EEG records.
It categorises seizure-like events with four levels of confidence, enhancing the efficiency and accuracy of interpretation, the brain health solutions developer claimed.
Additionally, REMI Vigilenz AI has received FDA clearance with a Predetermined Change Control Plan (PCCP), a novel initiative designed to assist artificial intelligence (AI)/ machine learning (ML) enabled devices in adapting to changes.
With this authorised PCCP, Epitel anticipates training REMI Vigilenz AI to enhance its performance to identify potential seizures over time, thereby assisting physicians in delivering improved clinical care.
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.”
The company aims to make both new technology platforms available through select practices later this year.
In 2022, Epitel secured $12.5m in a Series A financing round to support its REMI platform’s initial pilot and further development.
The digital health company is venture-backed by Catalyst Health Ventures, Genoa Ventures, Dexcom, OSF Ventures, and others.
