Epitel announced received FDA 510(k) clearance for two new patient-focused brain health offerings. The FDA cleared the Remi remote EEG monitoring system for ambulatory use and the Remi Vigilenz AI for event detection. Remi for ambulatory use allows for EEG recording in outpatient and home environments for an extended duration. Vigilenz AI analyzes and marks Remi EEG records for potential electrographic seizures to assist with ease and accuracy of interpretation.
Related: Hyalex Orthopaedics announces first cases with synthetic knee cartilage implant
Remi ambulatory allows for an extended EEG in the comfort of the home while going about daily activities. It leverages the same sensors used in the Remi platform for healthcare facility use and adds a mobile computing platform. This allows patients and caregivers to mark when they’ve experienced an event or suspected event.
Epitel designed Remi Vigilenz AI for detection to leverage state-of-the-art proprietary machine learning. It identifies and annotates potential seizure events in Remi EEG records. The FDA also cleared the AI with a predetermined change control plan (PCCP), a program that helps AI/ML-enabled devices manage change.
The company plans to make both new platforms available through select practices later this year.
“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,” said Mark Lehmkuhle, CEO and co-founder of Epitel. “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.”
