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Epitel Expands AI Portfolio With A Fourth FDA 510(k) Clearance for REMI

Epitel, a leader in AI for patient-focused brain health technologies, announced today it received U.S. Food and Drug Administration (FDA) 510(k) clearance for REMI Vigilenz™ AI For Bedside Notifications. REMI Vigilenz AI For Bedside Notifications conducts an automated analysis of EEG data collected by the REMI™ wireless wearable EEG System in near real-time. Notifications occur when the algorithm recognizes seizure characteristics within a section of EEG.