The system is intended for neurological monitoring in infants and pediatric patients aged one year and above. Credit: Saylakham / Shutterstock.
The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless electroencephalogram (EEG) System for neurological monitoring in infants and paediatric patients aged one year and above.
According to the company, the system’s design offers a “comfortable” experience, averting children from wire pulling or electrode displacing, which could compromise the integrity of the data.
Additionally, the system’s setup and extended monitoring claims to offer wireless brain health examination at home or hospital with no constraints associated with a tethered system.
This is the fifth 510(k) clearance for the Epitel’s REMI portfolio, with the first clearance obtained in March 2021.
The REMI System is suitable for healthcare settings requiring near real-time or remote EEG monitoring and for ambulatory settings that require remote monitoring.
It uses disposable, single-use wearable sensors to capture and wirelessly transmit brain activity for up to 30 days.
The accompanying REMI Mobile application displays setup information for medical professionals and delivers notifications to medical staff and ambulatory users.
Data from the connected REMI Sensors is transmitted to the REMI Cloud for storage and review using qualified EEG viewing software.
The REMI System does not provide diagnostic conclusions about the patient’s condition, and it is intended as a monitor of physiological signals for adult and paediatric subjects over one-year-old, as stated by the company.
Epitel CEO Steve Pacelli said: “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.”
In April 2024, the company [obtained 510(k) clearance](https://www.medicaldevice-network.com/news/epitels-remi-510k-clearance/) for its REMI Remote EEG Monitoring System for Ambulatory (at home) use and REMI Vigilenz AI For Event Detection.