INTENDED FOR U.S. AUDIENCES ONLY

RETHINK WHAT'S POSSIBLE IN AMBULATORY EEG MONITORING

THE CURRENT AMBULATORY EEG MONITORING LANDSCAPE IS OUTDATED

A 72-hour monitoring window may not be enough time to capture potential electrographic seizure activity

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Traditional readouts from EEGs are lengthy and expensive due to the time required to facilitate them

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Wired systems are uncomfortable and can be distressing to patients

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PROVEN ACCURACY, SIMPLIFIED WITH MORE TIME FOR EVENT DETECTION

With extended monitoring, there is a greater opportunity to capture potential electrographic seizure activity. REMI™ provides a simplified, accurate view of potential electrographic seizure activity for patients at home, which includes recordings from 4 sensors (8 electrodes), creating a 10-channel montage.

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REMI Ambulatory is powered by REMI Vigilenz™ AI for Event Detection, which was trained to identify potential electrographic seizure activity within an EEG record. Its performance was evaluated through a clinical validation consisting of 50 patient records with over 2600 hours of recorded EEG activity, including 87 known electrographic seizures.

In one study, physicians identified 100% of electrographic seizure events recorded in at least 1 location where the REMI Sensors were placed.

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Epileptologists found that ≥79% of all seizures were visible at all sensor locations, indicating that REMI users can expect to detect and record the vast majority of electrographic seizure activity in at least 1 location.

With just 4 wireless, disposable, and discrete sensors, REMI’s truly wireless monitoring system allows patients to go about their lives

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REMI SENSOR

Sleek soft-touch surface

1/4" Height

1 1/16" Width

PROVEN SUCCESS IN EVENT DETECTION

0.162 FP/hr

0.176 FP/hr

86.2 %

92.2 %

EVENT-LEVEL FAR ACROSS ALL PATIENTS

EVENT-LEVEL SENSITIVITY ACROSS ALL PATIENTS

MEAN PER-PATIENT FAR

7 MEAN PER-PATIENT SENSITIVITY

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Advanced AI technology works seamlessly with Persyst™ Mobile, the most common EEG monitoring platform.

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FAR, false alarm rate.

INFORMATION AT YOUR FINGERTIPS

Confidence levels are clearly shown along a tiered scale

REMI Vigilenz AI for Event Detection is designed to highlight regions of EEG that may correspond to electrographic seizure events and to report its confidence that a detected potential event represents a true positive electrographic seizure event.

When choosing REMI, consider what the groundbreaking AI technology behind the device can do for you and the care of your patients.

CONFIDENCE LEVEL

7

(95%-100%)

VERY HIGH

(80%-94%)

HIGH

(50%-79%)

MODERATE

(0-49%)

LOW

ANNOTATIONS

for providers to review

EEG RECORDINGS CONTAIN ANNOTATIONS

where potential electrographic seizure activity is detected

AUTHORIZED PREDETERMINED CHANGE PROTOCOL PLAN

REMI Vigilenz AI for Event Detection has been cleared by the FDA with an Authorized Predetermined Change Control Plan (PCCP). Under this PCCP, periodic updates are expected to be made to REMI Vigilenz AI for Event Detection to further improve its performance.

LOOK TO REMI FOR A NEW ERA OF WIRELESS EEG MONITORING

REMI FOR HEALTHCARE FACILITIES

REMI SYSTEM SAFETY INFORMATION

INDICATIONS
REMI Remote EEG Monitoring System 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 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 up to 30 days.

The 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 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).

Please click here for full Instructions for Use for REMI™ Healthcare Facility, REMI™ Ambulatory (Clinician),

REMI™ Ambulatory (Patient).

REMI Vigilenz AI For Event Detection Indications for Use

REMI Vigilenz AI For Event Detection is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI Vigilenz AI For Event Detection 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 Vigilenz AI For Event Detection 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 Vigilenz AI For Event Detection is indicated for use with adult and pediatric patients (6+ years).

REMI Vigilenz AI For Event Detection does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient’s condition to the user.

Please click here for full Instructions for Use for REMI Vigilenz™ AI for Event Detection.

References: 1. Frankel MA, Lehmkuhle MJ, Watson M, et al. Electrographic seizure monitoring with a novel, wireless, single-channel EEG sensor. Clin Neurophysiol Pract. 2021;6:172-178. doi:10.1016/j.cnp.2021.04.003 2. Elger CE, Hoppe C. Diagnostic challenges in epilepsy: seizure under-reporting and seizure detection. Lancet Neurol. 2018;17(3):279-288. doi:10.1016/S1474-4422(18)30038-3 3. Hernández-Ronquillo L, Thorpe L, Dash D, et al. Diagnostic accuracy of the ambulatory EEG vs. routine EEG for first single unprovoked seizures and seizure recurrence: the DX-seizure study. Front Neurol. 2020;11(223):1-6. doi:10.3389/fneur.2020.00223 4. Davey Z, Gupta PB, Li DR, Nayak RU, Govindarajan P. Rapid response EEG: current state and future directions. Curr Neurol Neurosci Rep. 2022;22(12):839-846. doi:10.1007/s11910-022-01243-1 5. Supporting patients with sensory issues through video-EEG monitoring. Seer Medical. Accessed November 3, 2023. https://seermedical.com/eeg-sensory-issues 6. Frankel MA, Lehmkuhle MJ, Spitz MC, Newman BJ, Richards SV, Arain AM. Wearable reduced-channel EEG system for remote seizure monitoring. Front Neurol. 2021;12:728484. doi:10.3389/fneur.2021.728484 7. REMI Vigilenz™ AI For Event Detection. Instructions for use. Epitel, Inc.; January 2024. 8. REMI™ Remote EEG Monitoring System. Instructions for use. Epitel, Inc.; January 2024.