Ceribell Status Epilepticus Monitor

by Ceribell  · Based in United States →Transforming the diagnosis and management of patients with serious neurological conditions.
Critical Care Emergency Medicine Neurology

Contact vendor
Regulatory Status Disclosed

Overview

The Ceribell System is a novel, point-of-care electroencephalography (EEG) platform designed to rapidly diagnose and continuously monitor patients with serious neurological conditions in acute care settings. It combines proprietary, highly portable hardware with sophisticated artificial intelligence (AI)-powered algorithms. The system consists of a disposable 10-electrode headband, a pocket-size EEG recorder with the Brain Stethoscope® feature, and a HIPAA-compliant cloud portal for real-time remote EEG review. The AI algorithm, named Clarity®, continuously monitors for seizure activity and provides instantaneous bedside alerts for suspected status epilepticus in adults and continuous seizures in neonates and pediatric patients. The Ceribell System aims to make EEG widely available, more efficient, and cost-effective, improving the diagnosis and treatment of patients at risk for seizures, delirium, and potentially LVO stroke. It is utilized in intensive care units and emergency rooms across the U.S.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Rapid EEG setup within minutes with minimal training
  • AI-powered Clarityu00ae algorithm for continuous seizure monitoring and alerts
  • Brain Stethoscopeu00ae feature for immediate audible seizure detection
  • Highly portable and disposable EEG headband and pocket-size recorder
  • Cloud-based portal for real-time remote EEG review on any device
  • EMR integration for streamlined data flow and reporting
  • Customizable notifications and smart EEG reports
  • EEG Reference Library for learning and comparison
  • 24/7 continuous monitoring and seizure burden display
  • Signal quality equivalent to conventional EEG

Use Cases

  • Rapid diagnosis of nonconvulsive status epilepticus (NCSE)
  • Continuous monitoring for seizures and electrographic status epilepticus (ESE)
  • Delirium screening and monitoring in critical care settings
  • Aid in detection and monitoring of Large Vessel Occlusion (LVO) stroke
  • Guiding treatment plans and assessing medication effectiveness
  • Reducing ICU length of stay and improving patient outcomes

What Physicians Need to Know

EEG Interpretation AI
The Ceribell system utilizes a proprietary AI algorithm called Clarity (and ClarityPro) to interpret EEG signals in real-time, analyzing data every 10 seconds. ClarityPro is the first acute care device to be FDA indicated for stand-alone diagnosis of electrographic status epilepticus (ESE) in adults. The AI provides automated cues to highlight significant areas of concern within the EEG, aiding neurologists in their review. It has demonstrated high sensitivity (95%) and specificity (97%) for alerting to suspected status epilepticus at u226590% seizure burden.
Seizure Detection
The Ceribell Status Epilepticus Monitor is specifically designed for the rapid diagnosis and continuous monitoring of Electrographic Status Epilepticus (ESE) and non-convulsive seizures in adult patients at risk. It continuously monitors brain activity and measures 'seizure burden' in real-time, displaying the percentage of time a patient is in seizure over a rolling five-minute window. Automatic visual and audible alerts are generated at the bedside when sustained seizure activity or a seizure burden of 90% or higher is detected.
Triage Prioritization Speed
The system enables rapid bedside EEG setup within minutes (e.g., under five minutes) by any trained provider, eliminating the need for an EEG technician. This significantly shortens the time to diagnosis of status epilepticus and non-status epilepticus conditions compared to conventional EEG, which can take hours. This rapid deployment supports fast triage and diagnosis, leading to quicker treatment decisions and potentially improved patient outcomes.
Mobile Notification System
The Ceribell system provides notifications for detected seizure prevalence (e.g., 'Frequent,' 'Abundant,' 'Continuous') via on-screen display on the Pocket EEG Device and optional email messages to clinicians. Real-time EEG data is streamed to a secure, cloud-based portal, allowing physicians to remotely review EEG data, seizure burden trends, and alerts from any internet-connected device.
Physician Tip

Utilize Ceribell for rapid, point-of-care EEG assessment in patients with suspected status epilepticus or altered mental status, especially when immediate conventional EEG is unavailable. Leverage the real-time seizure burden display and AI-powered alerts to guide urgent treatment decisions and monitor medication effectiveness. Remember that while the AI provides critical diagnostic aid, a qualified clinician's review of the underlying EEG remains essential for comprehensive neurological assessment. The ease of application by trained staff can significantly reduce diagnostic delays and improve time-to-treatment.

The Ceribell Status Epilepticus Monitor is a self-contained system comprising a proprietary patient headband with integrated electrodes, a portable bedside recorder, and specialized software. The software, including the Clarity AI algorithm, analyzes EEG signals acquired by the headband and recorder. Real-time EEG data and AI-generated alerts are streamed to a secure, cloud-based portal, enabling remote access and review by clinicians. The system is designed for seamless integration into acute care workflows without requiring external EEG technicians for setup.

Details

Category Neurology AI, Triage & ER/ICU AI
Pricing Contact vendor
  • Pricing is not publicly disclosed; potential for New Technology Add-on Payment (NTAP) and existing CPT codes for reimbursement
DeploymentPoint-of-care hardware with a cloud-based portal for data transmission and review.
Compliance
BAA Available Yes AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Ceribell Status Epilepticus Monitor software (K223504, cleared 05/23/2023) is indicated for the diagnosis of Electrographic Status Epilepticus in adult patients at risk for seizure. The Ceribell System is also FDA 510(k) cleared for indicating suspected seizure activity and continuous seizures in neonates and pediatric patients, and for delirium monitoring. It has received Breakthrough Device Designation for Large Vessel Occlusion (LVO) stroke detection.

Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Neurology

What the Web Says

The Ceribell Status Epilepticus Monitor is an AI-powered, point-of-care EEG system designed for rapid detection and continuous monitoring of seizures, particularly non-convulsive status epilepticus, in acute care settings. It aims to reduce diagnosis time and improve patient outcomes by providing immediate EEG data and AI-driven alerts. The system has received FDA 510(k) clearance for diagnosing electrographic status epilepticus and a New Technology Add-on Payment (NTAP) from CMS.

Overall: Mixed

Strengths

  • Rapid setup and diagnosis, significantly reducing the time to EEG acquisition compared to conventional EEG.
  • Easy to use and apply by various healthcare providers, not just trained EEG technologists.
  • Improved clinical accuracy and confidence in diagnosing seizures, with high sensitivity and specificity for detecting status epilepticus.
  • Potential to reduce unnecessary treatments and expedite patient disposition.
  • Can be used in various hospital settings, including emergency departments, ICUs, and isolation rooms (e.g., for COVID-19 patients).
  • Associated with shorter ICU length of stay and better neurological outcomes.

Limitations

  • Limited 8-channel montage does not replace a full 18-channel EEG for comprehensive seizure characterization or localization.
  • AI (Clarity algorithm) has been reported by some clinicians to be unreliable, potentially missing focal seizures or overcalling metabolic waveforms as seizures.
  • High cost of single-use headbands makes the running costs of the device expensive.
  • Can generate additional workload for reading teams due to its accessibility and frequent use.
  • Difficulty in recording data for longer than two hours due to significant muscle and electrode artifacts.
  • Some clinicians do not trust the AI, and there's a perceived misunderstanding of its utility by non-neurologists.

Based on reviews from: Ceribell, Clinical Studies | Ceribell, Ceribell EEG shortens seizure diagnosis and workforce time and is useful for COVID isolation - PMC, 12 Ceribell Customer Reviews & References | FeaturedCustomers, Can anyone provide anecdotes or proof of Ceribell's mediocrity? : r/neurology - Reddit, The Efficacy of CERIBELL in Acute Neurological Conditions in the Emergency Room (P16-8.006), Ceribell issues : r/neurology - Reddit, Automated Seizure Detection and Management using CERIBELL: A single center cohort study (P10-1.006) | Neurology, EEG : r/neurology - Reddit, Ceribell AI-powered point-of-care EEG is revolutionizing seizure management in acute care, EEG machine without ECG and EOG sensors : r/neurology - Reddit, The Ceribellu2122 Rapid Response EEG System Demonstrates Fast Seizure Diagnosis Leading To 40% Change In Physician Treatment Decisions - BioSpace, Ceribell Point-of-Care EEG Platform Outperforms Conventional EEG Across Various Outcomes in Mutlicenter Study | NeurologyLive, New Clinical Evidence Links Ceribell Point-of-Care EEG to Shorter Hospital Stays and Better Functional Outcomes Compared to Conventional EEG - PR Newswire, Ceribell Status Epilepticus Monitor - Alternative Pathway (Breakthrough Devices) - NTP22101439A1J - MEARIS - CMS, New Clinical Evidence Links Ceribell Point-of-Care EEG to Shorter Hospital Stays and Better Functional Outcomes Compared to Conventional EEG | Wed, 10/16/2024 - 16:05, Ceribell Experience? : r/MedicalDevices - Reddit, Denis Prudencio Demonstrates the Ceribell EEG System - YouTube, Time is brain: new technology is a game-changer for patients with seizures - Swedish, Indications, Safety & Warnings - Ceribell, Ceribell's AI EEG system reduces stay in ICU, study finds - Clinical Trials Arena, Ceribell Case Study: ED NCSE Ruled Out - YouTube, Evaluating the Clinical Impact of Rapid Response Electroencephalography: The DECIDE Multicenter Prospective Observational Clinical Study - PMC

Last updated: 2026-07-17

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Press & Coverage

GLOBE NEWSWIRE via Ceribell Inc.
Ceribell Receives FDA Breakthrough Device Designation for LVO Stroke Detection and Monitoring Solution
Ceribell announced that its Large Vessel Occlusion (LVO) stroke detection and monitoring solution received FDA Breakthrough Device Designation, utilizing its existing EEG hardware with an AI-based algorithm for early LVO stroke detection in hospitals.
2026-01
StockTitan
Ceribell Announces New Critical Care Medicine Publication Reinforcing Link Between Seizure Burden Measured by Clarity AI Algorithm and Neurological Outcomes
A new Critical Care Medicine publication highlights the connection between seizure burden, as measured by Ceribell's Clarity AI algorithm, and neurological outcomes at discharge. The multicenter study found that higher AI-detected seizure burden was associated with greater odds of severe disability or death.
2026-06
GLOBE NEWSWIRE via Ceribell Inc.
Ceribell Reports First Quarter 2026 Financial Results
Ceribell reported Q1 2026 revenue of $26.5 million, a 29% increase year-over-year, with 680 active accounts and an 87% gross margin. The company also initiated the commercial launch of its neonate and pediatric products.
2026-05
GovInfo (Federal Register)
Federal Register/Vol. 91, No. 71/Tuesday, April 14, 2026/Proposed Rules
The Federal Register includes a proposed rule from CMS regarding the Ceribell Status Epilepticus Monitor, which would no longer be considered 'new' for New Technology Add-on Payment (NTAP) purposes, proposing to exclude cases reporting specific ICD-10-CM diagnosis codes.
2026-04
MedDeviceGuide
FDA Breakthrough Device Designation: Program Guide for 2026
This guide lists the Ceribell Status Epilepticus Monitor and Delirium Monitor as examples of rapid bedside EEG devices that have received FDA Breakthrough Device Designation, enabling earlier diagnosis of neurological emergencies.
2026-04
npj Digital Medicine (via PMC)
Artificial intelligence in neurology: opportunities, challenges, and policy implications
This peer-reviewed article discusses the Ceribell Status Epilepticus Monitor as an AI-enabled device for electrographic status epilepticus diagnosis from EEG waveforms, highlighting the role of AI in neurology.
2024-03
PR Newswire
Ceribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityProu2122 Software with Electrographic Status Epilepticus Diagnostic Indication
Ceribell announced that its new ClarityProu2122 software received 510(k) clearance from the FDA for electrographic status epilepticus diagnosis and secured CMS NTAP reimbursement.
2023-08
FDA
K223504 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification details the clearance of the Ceribell Status Epilepticus Monitor, indicating its use for the diagnosis of Electrographic Status Epilepticus in adult patients at risk for seizure.
2023-05

Videos

Product demos, reviews, and walkthroughs for Ceribell Status Epilepticus Monitor.

View all on YouTube

Frequently Asked Questions

The Ceribell monitor utilizes proprietary AI algorithms, such as Clarity and ClarityPro, to continuously analyze real-time EEG data, identifying patterns indicative of status epilepticus or other seizure activity. It calculates a 'seizure burden' and generates alerts when this burden exceeds a predefined threshold, aiming to provide rapid detection and facilitate timely treatment.
The Ceribell Rapid Response EEG system, including its ClarityPro AI algorithms for diagnosing electrographic status epilepticus (ESE), has received FDA 510(k) clearance for adults and for detecting seizures in neonates and pediatric patients. It adheres to HIPAA compliance standards, with EEG data streamed to a secure, cloud-based portal to ensure patient data privacy and security.
While traditional continuous EEG with expert interpretation remains the gold standard, the Ceribell AI aims to provide rapid, point-of-care detection, especially when immediate epileptologist review is not feasible. Clinical validation studies demonstrate high diagnostic accuracy, with reported sensitivity of 96.0% and specificity of 94.8% for status epilepticus detection, complementing comprehensive human interpretation.
The Ceribell system's use is generally covered by existing CPT codes for EEG monitoring. Additionally, its ClarityPro software has received New Technology Add-on Payment (NTAP) from CMS, allowing for potential reimbursement of up to $913.90 per eligible Medicare patient case, which can help offset operational costs and reduce overall hospital expenses.
Like all automated systems, the Ceribell AI may have limitations, including potential for false positives or negatives, particularly with significant artifact interference or in differentiating certain non-epileptic events. The diagnostic output is intended as an aid and requires integration with clinical context and review of raw EEG data by a trained clinician for definitive diagnosis.
The Ceribell system is designed for rapid, bedside setup by any trained healthcare provider within minutes, eliminating the need for specialized EEG technicians. It provides real-time AI-driven alerts and allows for remote review of EEG data via a secure portal, streamlining workflows and enabling quicker treatment decisions.

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

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