FDA OKs Epitel’s REMI Remote EEG Monitoring, AI Detection

Epitel has gained U.S. Food and Drug Administration (FDA) 510(k) clearances for two new technologies: REMI remote EEG monitoring system for ambulatory (at home) and REMI Vigilenz AI for event detection.
 
REMI for Ambulatory provides EEG recording in outpatient and home environments for an extended duration. REMI Vigilenz AI for event detection analyzes and marks REMI EEG record for potential electrographic seizures to help with ease and accuracy of interpretation.
 
Currently, the company explained, outpatient and ambulatory EEG monitoring is uncomfortable and inconvenient. Patients can’t go about daily activities because of a fully wired system. Some patients experience infrequent seizures that standard, 72-hour ambulatory EEG studies might miss, as well.
 
Epitel said REMI Ambulatory provides extended EEG in the home while going about daily life. It uses the same REMI sensors used in REMI for Healthcare Facility Use. It adds a mobile computing platform so patients and caregivers can mark when they’ve experienced an event or suspected event.
 
REMI Vigilenz AI for Event Detection leverages proprietary machine learning to identify and annotate potential seizure events in REMI EEG records. The platform categorizes seizure-like events with four levels of confidence, improving ease and speed of interpretation. The FDA also cleared REMI Vigilenz AI for Event Detection with a Predetermined Change Control Plan (PCCP), a new program to help AI/ML-enabled devices manage change.
 
REMI uses single use, single patient, disposable, wearable sensors to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days.
 
“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,” said Mark Lehmkuhle, Ph.D., CEO and co-founder of Epitel. “We are excited about how these two advances will shift the paradigm of brain health monitoring.”