Epitel’s Wireless Wearable EEG System Approved for Patients as Young as One Year Old

Epitel today announced that the FDA has granted another 510(k) clearance for the REMI Wireless EEG System, expanding the Indications for use of the device for infants and children one year of age and older.

Traditional EEG monitoring often involves equipment and wires. The REMI design facilitates a more comfortable experience that prevents a young child from pulling on wires or displacing electrodes that could disrupt data integrity. The setup and extended monitoring provide wireless brain health monitoring in either the home or hospital without the constraints of a tethered system.

This marks Epitel’s fifth FDA 510(k) clearance for the REMI portfolio. REMI was first cleared by the FDA in March 2021.

The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI System uses single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration of up to 30 days.

REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-shelf mobile computing platforms. REMI Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software.

REMI System does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI System is indicated for use with adult and pediatric patients (1+ years).