FDA clears Epitel remote monitoring tech, AI detection platform

A rendering of the Remi system. [Image from the Epitel website]Epitel announced today that it 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.

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 levarage state-of-the-art proprietary machine…

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