Epitel’s REMI Wireless Wearable EEG System Receives Expanded FDA Clearance for Patients as Young as One Year Old

Younger children and infants at least one year of age benefit from a wireless system that integrates brain health monitoring into a child’s regular routine with drastically less disruption than traditional wired systems

Epitel, a leader in AI-driven brain health solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted another 510(k) Clearance for the REMI™ Wireless EEG System, expanding the Indications for Use of their revolutionary wireless EEG system in infants and children one year of age and older. This designation underscores the potential of REMI to revolutionize neurological monitoring in one of the most vulnerable patient populations.

Traditional EEG monitoring often involves cumbersome equipment and wires, which can be especially distressing for both the child in need of care and their family. The REMI design facilitates a comfortable experience that prevents a young child from pulling on wires or displacing electrodes that could disrupt data integrity. The easy setup and extended monitoring provide truly wireless brain health monitoring in either the home or hospital without the constraints of a tethered system.

“Epitel continues to make EEG monitoring accessible and deployable for all communities. This new clearance reflects our commitment to improving brain health across all age groups, demographics, and geographies, ensuring that even the youngest patients receive timely and accurate care,” said Steve Pacelli, the newly appointed Chief Executive Officer of Epitel.

This marks Epitel’s fifth FDA 510(k) Clearance for the REMI portfolio. REMI was first cleared by the FDA in March 2021. For more information, please visit www.epitel.com

REMI Remote EEG Monitoring Indications For Use

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).

About Epitel, Inc.

Epitel™ is a digital health company modernizing brain health solutions to improve seizure monitoring and detection. By leveraging a proprietary cloud-based wearable sensor system and innovative AI technologies, Epitel empowers better treatment decisions by making EEG readily deployable and accessible. Headquartered in Salt Lake City, Epitel is dedicated to advancing neurological care across diverse healthcare settings. Visit www.epitel.com to learn more.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250331373254/en/