REMI-AI Rapid Detection Module (REMI-AI RDM)

by Epitel  · Based in United States → — Modernizing brain health solutions to improve seizure monitoring and detection.
Emergency Medicine Hospital Medicine Neurology

Contact for pricing
Regulatory Status Disclosed

Overview

The REMI-AI Rapid Detection Module (REMI-AI RDM) by Epitel is an FDA-cleared artificial intelligence (AI) tool designed for the near real-time detection of electrographic seizures. Integrated into the broader REMI Remote EEG Monitoring System, REMI-AI RDM leverages a cloud-based wearable sensor system and advanced AI technologies to provide accessible and reliable brain health insights. The system utilizes disposable, wireless EEG sensors that can be easily applied, even by non-EEG technicians, to capture high-fidelity EEG recordings for extended durations, up to 30 days.

REMI-AI RDM conducts automated analysis of EEG data and provides notifications to qualified clinicians regarding the prevalence and confidence of potential electrographic seizures, specifically when a combined prevalence of 10% or greater (indicating at least 30 seconds of activity) is detected within a rolling 5-minute window. These notifications are delivered through the REMI Mobile software application, which also facilitates data transmission to the secure REMI Cloud for storage and review on qualified EEG viewing software. The tool is intended for use in non-ICU healthcare settings for adult and pediatric patients (6+ years), aiming to reduce delays in seizure identification and improve patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated analysis of EEG data
  • Near real-time electrographic seizure detection
  • Notifications of potential electrographic seizures with confidence levels and prevalence
  • Integrated with REMI Remote EEG Monitoring System
  • Wearable, wireless EEG sensors (part of the REMI system)
  • Cloud-based data analytics and storage
  • Mobile application for notifications and data transmission (REMI Mobile)
  • High-fidelity EEG recordings
  • Easy application by non-EEG technicians
  • Supports extended monitoring duration (up to 30 days for REMI system)

Use Cases

  • Electrographic seizure detection in non-ICU healthcare settings
  • Remote EEG monitoring in healthcare facilities
  • Ambulatory (at-home) EEG monitoring (as part of the REMI system)
  • Assisting qualified clinicians in assessing EEG records
  • Improving diagnosis, treatment, and management of seizures
  • Rapidly deployable triage tool for seizure detection in emergency rooms

What Physicians Need to Know

EEG Interpretation AI
REMI Vigilenz AI for Event Detection analyzes REMI EEG recordings, marking sections that may correspond to neurological events of interest, specifically potential electrographic seizures. It provides confidence levels for detected events and is intended as an aid for qualified physicians, not a diagnostic tool.
Seizure Detection
The core function of REMI-AI RDM is the detection of potential electrographic seizures, particularly those lasting at least 10 seconds. It provides notifications when seizure prevalence of 10% or greater (indicating at least 30 seconds of activity within a 5-minute rolling window) is detected. The AI has demonstrated high sensitivity (90-100% for detecting individuals with seizures, 90% for individual focal onset seizures by the algorithm). It is indicated for use in non-ICU healthcare settings and ambulatory settings, but not for detecting electrographic status epilepticus.
Triage Prioritization Speed
The REMI system, with its rapid deployment (EEG monitoring initiated within minutes) and near real-time data transmission, serves as a rapidly deployable triage tool for seizure detection in neurologic emergencies. Notifications for potential seizures are provided in near real-time, though delays of up to several minutes can occur between event detection and notification.
Mobile Notification System
The REMI Mobile software application displays user setup information and delivers notifications to medical professionals and ambulatory users regarding potential electrographic seizures detected by REMI-AI RDM.
Physician Tip

REMI-AI RDM is an assistive tool for EEG review, not a standalone diagnostic. Physicians should exercise professional judgment in interpreting the AI's notifications, which include prevalence and confidence levels for potential electrographic seizures. The system is validated for non-ICU and ambulatory settings and is not indicated for detecting electrographic status epilepticus. Be aware that notifications may have a delay of several minutes, so it should not replace real-time monitoring. Its utility is particularly strong for extended monitoring to capture infrequent seizure events.

The REMI system, including REMI-AI RDM, integrates with the REMI Mobile software application, which transmits data to a secure REMI Cloud. The data is then prepared for review on qualified EEG viewing software, notably Persystu2122 Mobile, a widely used EEG monitoring platform. The system communicates wirelessly via Bluetooth with its sensors and requires a secure WiFi connection for the REMI tablet.

Details

Category Neurology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentCloud-based, with wearable sensors and mobile application.
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The REMI-AI Rapid Detection Module (REMI-AI RDM) (K240408) is a seizure detection module integrated into the REMI Remote EEG Monitoring System. It was cleared by the FDA on October 17, 2024, and is indicated for use in non-ICU healthcare settings for adult and pediatric patients (6+ years) to provide notifications of potential electrographic seizures with a combined prevalence of 10% or greater within a rolling 5-minute window of EEG.

Integrations
EHR Not specified
Specialties Emergency Medicine, Hospital Medicine, Neurology

What the Web Says

The REMI-AI Rapid Detection Module (REMI-AI RDM) is an AI-powered seizure detection module integrated into Epitel's REMI Remote EEG Monitoring System. It is designed for use in non-ICU healthcare settings and analyzes EEG data in near real-time to provide notifications of potential electrographic seizures. The system aims to make EEG monitoring more accessible and efficient, particularly in facilities without 24/7 EEG coverage or specialized technicians. The device is intended to assist qualified clinicians in their review of EEG records, rather than providing a diagnostic conclusion itself.

Overall: Positive

Strengths

  • Automated, near real-time detection of potential electrographic seizures.
  • Increases accessibility of EEG monitoring in non-ICU settings and facilities lacking specialized staff.
  • Wireless system allows patients to move freely and can be used for extended durations (up to 30 days).
  • Annotates EEG records with detected events, confidence levels, and duration to aid physician review.
  • FDA 510(k) cleared with a Predetermined Change Control Plan (PCCP), allowing for performance-enhancing updates without additional FDA review.
  • Can be initiated quickly and is reimbursable using existing codes.

Limitations

  • Not indicated for use in ICUs or for the detection of electrographic status epilepticus.
  • Notifications are not a substitute for real-time EEG monitoring by a trained expert.
  • Does not provide diagnostic conclusions or make treatment recommendations.
  • Delays of up to several minutes can occur between event detection and notification.
  • Some neurologists have expressed skepticism about machine learning in EEG interpretation.
  • Lower channel count compared to traditional EEG systems, which may limit spatial coverage for seizure onset zone localization.

Based on reviews from: accessdata.fda.gov, BioUtah, PMC, Practical Patient Care, YouTube, Neurology Today, BioSpace

Last updated: 2026-07-18

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate REMI-AI Rapid Detection Module (REMI-AI RDM)

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

accessdata.fda.gov
510(k) Premarket Notification - K240408 REMI-AI Rapid Detection Module (REMI-AI RDM)
The FDA granted 510(k) clearance for Epitel's REMI-AI Rapid Detection Module (REMI-AI RDM) on October 17, 2024. This regulatory announcement details the device's indications for use in non-ICU healthcare settings for automated analysis of EEG data to provide notifications of potential electrographic seizures.
2024-10
FDA.report
Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
This entry lists the REMI-AI Rapid Detection Module (REMI-AI RDM) by Epitel, Inc. under the product code OMB for Automatic Event Detection Software For Full-Montage Electroencephalograph, with an approval date of October 17, 2024. It categorizes the device as Class II (performance standards) in Neurology.
2024-10
accessdata.fda.gov
REMI-AI Rapid Detection Module (REMI-AI RDM) (K240408)
This FDA page provides a direct link to the 510(k) premarket notification for the REMI-AI Rapid Detection Module (REMI-AI RDM), confirming its clearance and providing access to detailed regulatory information.
2024-10
Innolitics
Command Line as a Medical Device (CLaMD)
This article, updated in May 2025, references the REMI-AI Rapid Detection Module (REMI-AI RDM) in the context of medical devices that do not have a direct user interface, with its outputs handled by the broader REMI System.
2025-05
Epitel.com
Epitel - Physician Ai Tools
Epitel's own website highlights the REMI-AI Rapid Detection Module (REMI-AI RDM) as one of their healthcare AI tools.
2026-04

Videos

Product demos, reviews, and walkthroughs for REMI-AI Rapid Detection Module (REMI-AI RDM).

Loading videos...

View all on YouTube

Frequently Asked Questions

The REMI-AI Rapid Detection Module (REMI-AI RDM) is integrated into the REMI Remote EEG Monitoring System and conducts automated analysis of EEG data in near real-time. It provides notifications of potential electrographic seizures, specifically when seizure prevalence of 10% or greater (indicating seizure activity of at least 30 seconds within a 5-minute rolling window) is detected, within non-ICU healthcare settings. These notifications are presented through the REMI Mobile software application to aid qualified clinicians in their review.
REMI-AI RDM has received FDA 510(k) clearance, indicating it is substantially equivalent to predicate devices for its intended use. For patient data privacy, any AI tool handling Protected Health Information (PHI) must comply with HIPAA's Privacy, Security, and Breach Notification Rules, which typically involves features like end-to-end encryption, role-based access controls, comprehensive audit trails, and Business Associate Agreements (BAAs) with vendors.
REMI-AI RDM is not validated for, nor indicated for, the detection of electrographic status epilepticus and does not provide a diagnostic conclusion about the patient's condition. While specific accuracy metrics for REMI-AI RDM in real-world settings beyond its validation study were not detailed, AI systems generally face limitations such as potential biases if trained on unrepresentative datasets, and their performance can vary across diverse clinical settings.
REMI-AI RDM functions as an aide to the qualified physician's EEG review, marking sections of EEG that may correspond to neurological events of interest, rather than replacing traditional EEG interpretation. It offers near real-time analysis to flag potential seizures, complementing the in-depth review by a clinician. Other AI tools in healthcare vary widely, from diagnostic imaging AI to clinical decision support systems, each with specific applications and integration methods.
Specific pricing for REMI-AI RDM is not publicly available in the search results. However, diagnostic AI systems in healthcare typically range from $50,000 to $300,000 or more for implementation, with additional costs for regulatory pathways like FDA 510(k) submissions, which can be $200,000 to $500,000. Reimbursement for AI-powered medical devices is an evolving area, often depending on established CPT codes for the underlying service (e.g., EEG monitoring) and specific payer policies.
REMI-AI RDM is explicitly intended to be used by qualified clinicians who will exercise professional judgment in their interpretation of the information provided. The module serves as an aide to the physician's review, highlighting potential electrographic seizures, but it does not make diagnostic conclusions. This emphasizes that AI in medical diagnostics is a tool to augment human capabilities, requiring continuous human oversight to ensure patient safety and ethical practice.

Related Tools

Cercare Medical Oncology Virtual Expert
Cercare Medical
Neurology AI
Cercare Medical's Oncology Virtual Expert is an AI-powered brain tumor segmentation module that provides fast, consistent, and semi-automated tumor analysis from standard MRI data, designed for on-premise deployment within existing clinical radiology workflows.
CoLumbo C-Spine
Smart Soft Healthcare AD
Clinical Decision Support & Reference
CoLumbo C-Spine is an AI-powered software that processes and analyzes cervical spine MRI exams, assisting clinicians in diagnosis and assessment.
MeRT System
Wave Neuroscience
Mental & Behavioral Health AI
MeRT (Magnetic e-Resonance Therapy) is an advanced, personalized form of TMS that uses your own brainwave data to guide treatment. It's a non-invasive, drug-free option designed to help the brain communicate more efficiently so symptoms of conditions like depression, anxiety, PTSD, TBI, autism, and more can improve.
Brainomix 360 Hyperdensity
Brainomix Limited
Neurology AI
Brainomix 360 Hyperdensity is an AI-powered neuroimaging software tool that detects and quantifies brain hyperdensities on CT scans, forming a crucial part of the Brainomix 360 Stroke platform for rapid and accurate stroke assessment.
SOMNUM
HoneyNaps
Clinical Decision Support & Reference
SOMNUM is an AI-enabled medical software tool by Honeynaps Co., Ltd. that provides comprehensive sleep analysis to aid in the diagnosis and management of sleep disorders.
DETECT-ME/CFS project
DETECT-ME/CFS project (ME/CFS Research Foundation)
Clinical Decision Support & Reference
The DETECT-ME/CFS project is developing an AI-supported clinical decision support system to improve the rapid and reliable diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

See all Neurology AI tools →

More from Epitel

REMI AI Discrete Detection Module
Epitel
Neurology AI
Epitel's REMI AI Discrete Detection Module is an FDA-cleared AI tool that provides automated, near real-time detection of potential electrographic seizures from wearable EEG data, enhancing brain health monitoring in both healthcare facilities and ambulatory settings.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed REMI-AI Rapid Detection Module (REMI-AI RDM)

Funded through the company that built this tool.

AI Tool Finder
AI-powered search. Results may not be comprehensive.