Epitel has secured an expanded 510(k) clearance from the US Food and Drug Administration (FDA) for its REMI Wireless electroencephalogram (EEG) System, enabling its use in patients as young as one year old.
The company believes that this regulatory milestone marks an expansion in the field of paediatric neurological monitoring, providing an alternative solution for a traditionally challenging patient demographic.
The REMI Wireless EEG System addresses limitations associated with conventional EEG systems, which typically involve complex setups with numerous wires and equipment.
These traditional systems often pose challenges for young patients, leading to discomfort and potential data integrity issues due to dislodged electrodes.
In contrast, Epitel’s device offers a wireless solution that mitigates these challenges by allowing for easy setup and extended monitoring. It operates in both home and healthcare environments without the constraints of wired connections.
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.”
Intended for use in various healthcare settings, the REMI Remote EEG Monitoring System supports near real-time and remote capabilities. It is particularly suited for ambulatory environments where traditional EEG setups may not be feasible.
The system utilises single-use, patient-specific wearable sensors designed to detect and transmit brain electrical activity wirelessly for periods of up to 30 days.
The REMI Mobile software application operates on standard commercial mobile devices, providing setup guidance and notifications for healthcare professionals. It is said to facilitate seamless data transmission from the sensors to the secure REMI Cloud for storage and subsequent analysis using qualified EEG viewing software.
While the REMI System does not offer diagnostic conclusions, it functions effectively as a monitor of physiological signals, catering to adult and paediatric patients aged one year and older.
This latest FDA clearance is the fifth in Epitel’s REMI product line. The company initially received FDA approval for REMI in March 2021.
In October 2024, Epitel gained additional clearance for REMI Vigilenz AI For Bedside Notifications, which enables automated analysis of EEG data collected by the system in near real-time conditions.
