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The REMI-AI Rapid Detection Module (REMI-AI RDM) is a seizure detection module which is integrated into the REMI Remote EEG Monitoring System and is only indicated for use within non-ICU (Intensive Care Unit) healthcare settings. REMI-AI RDM has not been validated for and is not indicated for detection of electrographic status epilepticus. REMI-AI RDM conducts automated analysis of REMI EEG data in near real-time and provides notifications of potential electrographic seizures (events) through the REMI System when seizure prevalence of 10% or greater (indicating seizure activity of at least 30 seconds within a 5-minute rolling window) is detected. When seizure prevalence is displayed, the notification also displays the corresponding event detection confidence. Notifications are intended to be used by qualified clinicians who will exercise professional judgment in their application. Detected events are also annotated in the associated REMI EEG record as an aide to the qualified physician's REMI EEG review. Delays of up to several minutes may occur between the detection of an event and the generation of an event notification, and are thus not a substitute for real-time monitoring. REMI-AI RDM does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI-AI RDM is indicated for use with adult and pediatric patients (6+ years).

REMI-AI RDM conducts automated analysis of EEG data collected by the REMI System in near real-time. REMI-AI RDM provides notifications of the prevalence and confidence of potential electrographic seizures, having a combined prevalence of 10% or greater, which correlates with a duration of at least 30 seconds of activity within a rolling 5 minute window of EEG. REMI-AI RDM notifications are presented through the REMI Mobile software application, and are intended to be used by qualified clinicians who will exercise professional judgment in their interpretation. Notifications include the prevalence and confidence value for the event and are marked in the associated EEG record in order to assist qualified clinicians in their assessment. REMI-AI RDM notifications identify when a section of EEG is consistent with seizure characteristics it has been trained to recognize. When a notification is presented, clinical context and facility procedures should inform next steps in patient evaluation and management. REMI-AI RDM does not make any treatment or management recommendations.

The REMI-AI Discrete Detection Module (REMI-AI DDM) is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI-AI DDM is intended to be used by physicians qualified to analyze and interpret EEG who will exercise professional judgment in using the information. As an aide to the qualified physician's REMI EEG review, REMI-AI DDM marks previously acquired sections of REMI EEG that may correspond to neurological events of interest indicative of potential electrographic seizures lasting at least 10 seconds in duration. REMI-AI DDM is indicated for use with adult and pediatric patients (6+ years). REMI-AI DDM does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient's condition to the user.

REMI-Al Discrete Detection Module (REMI-AI DDM) is a software as a medical device (SaMD) that automatically identifies and annotates discrete seizure-like events in previously acquired electroencephalography (EEG) traces to aid a qualified physician in their review of REMI EEG records. REMI-AI DDM analyzes previously acquired EEG data from 4-channel recordings obtained from bilateral, bipolar scalp EEG recordings at both the frontal and temporoparietal regions, collected and stored by the REMI Remote EEG Monitoring System. REMI-AI DDM analyzes EEG recordings and detects regions of the data that may correspond to electrographic seizures lasting at least 10 seconds in duration. These regions are annotated in the REMI EEG file as discrete events and are provided to assist in REMI EEG review.

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 uses single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days. The REMI System uses the REMI-Mobile software application that runs on qualified portable general purpose 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 does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).

The REMI System has three major components: 1) REMI Sensor A disposable EEG sensor which is placed on the patient's scalp using a conductive REMI Sticker 2) REMI Mobile A mobile medical application that is designed to run on a qualified commercial-off-the-shelf mobile computing platform (an Android tablet for use in healthcare settings, and a portable/wearable Android smartwatch for use in ambulatory settings), acquire EEG data transmitted from REMI Sensors and then transmit the EEG data and associated patient information via wireless encrypted transmission to, 3) REMI Cloud A HIPAA-compliant secure cloud storage and data processing platform where data is processed into a qualified EEG reviewing software format for neurological review. This 510(k) submission includes the addition of the Android smartwatch for ambulatory use and increases the duration of monitoring to up to 30 days.

The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of Epilog disposable Sensors - a single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REM-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software. REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professional healthcare facility environment. Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).

REMI amplifies the electroencephalogram (EEG) from a patient's scalp. After amplification, the EEG are sent to the REMI-Tablet running the REMI-Mobile Application. REMI-Mobile combines the EEG from four Epilog Sensors and patient information and relays the data to a cloud server running Persyst software. The EEG data is accessible through the Persyst Mobile interface. REMI is designed for use with adult and pediatric patients (6+). The user interface for the REMI-Tablet is an 10" LCD touchscreen display. The user interface for Epilog Sensors is a single button kevpad overmolded in each Sensor, REMI-Tablet power is through A/C adapter as well as limited onboard rechargeable battery. Epilog Sensor power is through a single-use primary coin cell. Using its wireless link, the Epilog Sensors can exchange EEG data and commands with the REMI-Mobile application running on the REMI-Tablet. REMI has three major components: 1) Epilog-D disposable EEG sensors, 2) REMI-Mobile - mobile OS application designed to run on a medical-grade tablet, acquire EEG data transmitted from Epilog devices along with user-entered patient and device information, and then transmit the EEG data and patient/device information via wireless encrypted WiFi to. 3) REMI-Cloud – A HIPAA-compliant cloud storage and data processing platform where data is processed into a format that a FDA-cleared (K171184) EEG reviewing software called Persyst can use, which will allow remote neurological review.