Ceribell Delirium Monitor System

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

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Regulatory Status Disclosed

Overview

The Ceribell Delirium Monitor System is a novel, point-of-care electroencephalography (EEG) platform designed to address the unmet needs of patients in acute care settings. It combines proprietary, highly portable, and rapidly deployable hardware (a disposable headband and a pocket-sized recorder) with sophisticated artificial intelligence (AI)-powered algorithms, including the Clarity AI.

The system enables rapid diagnosis and continuous monitoring of patients with neurological conditions, specifically focusing on delirium and seizures. It continuously analyzes EEG segments and notifies clinicians when patterns associated with delirium or seizure activity are detected, supporting more timely, reliable evaluation and continuous monitoring at the bedside.

The Ceribell System is designed for ease of use, allowing any trained healthcare provider to set it up within minutes. Data is transmitted to a HIPAA-compliant cloud portal, providing remote access to real-time EEG information for neurologists and other specialists.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Point-of-care EEG platform for rapid deployment
  • Proprietary, highly portable, and rapidly deployable hardware (headband and pocket-sized recorder)
  • AI-powered algorithms (Clarity AI) for continuous monitoring
  • Detection and monitoring of delirium
  • Detection and monitoring of seizures (including non-convulsive seizures and status epilepticus)
  • Real-time bedside alerts for critical neurological events
  • Cloud-based portal for remote EEG review and management
  • Rapid setup (under 5 minutes) with minimal training required
  • Continuous EEG monitoring and seizure burden display
  • Signal quality equivalent to conventional EEG

Use Cases

  • Screening and monitoring for delirium in critical care settings (ICU, ED)
  • Rapid diagnosis and continuous monitoring of seizures (non-convulsive seizures, status epilepticus)
  • Guiding treatment plans and assessing medication effectiveness in real-time
  • Reducing ICU length of stay and improving patient neurological outcomes
  • Facilitating remote neurology review and consultation
  • EEG monitoring for patients in respiratory isolation rooms

What Physicians Need to Know

EEG Interpretation AI
The Ceribell Delirium Monitor System uses a machine learning model to analyze EEG signals to detect features indicative of delirium. It continuously analyzes automated EEG segments and notifies clinicians upon detecting patterns associated with delirium. The system is built on Ceribell's existing FDA-cleared technology for detecting nonconvulsive seizures and electrographic status epilepticus (ESE), integrating both seizure and delirium monitoring into a single system. The AI algorithm, Clarity, also monitors seizure activity within a 5-minute interval to determine seizure burden. The system has been validated in prospective studies involving 225 critical care patients, showing a sensitivity of 81% and specificity of 81% for delirium detection. The continuous EEG system score correlated with CAM-ICU-7 delirium severity scores.
Seizure Detection
The Ceribell System is FDA-cleared for detecting seizures and delirium in intensive care units and emergency rooms. It uses an AI algorithm, Clarity, to monitor seizure activity within a 5-minute interval to determine the seizure burden and alerts bedside care providers if seizure activity occurs. The system simultaneously supports continuous seizure, electrographic status epilepticus (ESE), and delirium monitoring at the bedside.
Large Vessel Occlusion Detection
Ceribell has received FDA Breakthrough Device designation for its large vessel occlusion (LVO) stroke detection and monitoring solution. This solution uses the existing Ceribell hardware and applies an AI-based algorithm to interpret EEG signals for early detection of LVO stroke in hospitalized patients. The system is designed to enable more timely and continuous neurological monitoring at the bedside for LVO strokes, which are medical emergencies with high morbidity and mortality.
Mobile Notification System
The Ceribell Delirium Monitor System notifies clinicians upon detecting patterns associated with delirium to support rapid and objective treatment decision-making. The system displays results or triggers alarms based on the output of the Delirium Monitor.
Physician Tip

The Ceribell Delirium Monitor System offers continuous, objective monitoring for delirium and seizures, which can be difficult to distinguish clinically. Its AI-powered EEG analysis provides real-time insights, potentially leading to earlier diagnosis and intervention, especially in critically ill patients where traditional assessments may be challenging or delayed. The system's ability to track multiple neurological vital signs simultaneously at the bedside with a single device streamlines monitoring. For suspected LVO strokes, the system's early detection capabilities could be crucial for improving patient outcomes, as timely intervention is critical. Always verify changes in patient condition detected by the device with clinical assessments before initiating interventions. The system is intended to aid in screening and monitoring, not to replace clinical judgment.

The Ceribell Delirium Monitor System integrates with its proprietary single-use patient headband and bedside recorder. The software requires and interfaces with the Ceribell Pocket EEG for obtaining signals from the headband, displaying signals, and displaying results or triggering alarms. It is built on Ceribell's existing FDA-cleared technology, allowing for a unified platform that seamlessly integrates both seizure and delirium monitoring. The system is designed for use in acute-care settings like ICUs and emergency rooms.

Details

Category Neurology AI, Triage & ER/ICU AI
Pricing Contact for pricing
DeploymentCloud-based portal with bedside hardware (recorder)
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Neurology

What the Web Says

The Ceribell Delirium Monitor System is an FDA-cleared, AI-powered EEG system designed for rapid and continuous monitoring of delirium and seizures in critically ill patients, particularly in ICUs and emergency departments. It aims to make EEG monitoring more accessible and provide real-time, objective neurological insights to improve detection rates and management of delirium, which is often missed with traditional subjective assessments. The system has received FDA Breakthrough Device Designation for delirium monitoring and CMS has expanded reimbursement for it.

Overall: Mixed

Strengths

  • Rapid and easy to apply, providing interpretable data quickly.
  • Improves detection of delirium and seizures compared to clinical suspicion alone.
  • Can lead to shorter ICU stays and better neurological outcomes.
  • Reduces the need for specialized EEG technologists to be on-site 24/7, making EEG more accessible in various care settings.
  • Provides continuous monitoring, offering real-time insights into neurological status.
  • FDA cleared for both seizure and delirium detection, offering a unified view of neurological status.

Limitations

  • The AI aspects, particularly the Clarity AI for seizure detection, have been criticized by some physicians for not always accurately identifying seizure activity and having false positives.
  • It is a limited montage EEG and does not fully replace conventional EEG for all indications.
  • Can generate extra work for reading teams due to its accessibility and potential for both good and bad use cases.
  • Non-neurologists may not fully understand its limitations, leading to inappropriate use.
  • Some users have reported that the AI has failed to identify clear partial status epilepticus.
  • The system has been observed to overcall certain metabolic waveforms as seizures.

Based on reviews from: firstwordhealthtech.com, neurofounders.co, hlth.com, ceribell.com, reddit.com, medrxiv.org, mpo-mag.com, nih.gov, cms.gov, mddionline.com, withpower.com, youtube.com

Last updated: 2026-10-29

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Press & Coverage

Ceribell
Ceribell Announces Publication of Study Demonstrating the Clinical Utility of Its Rapid EEG System in the Diagnosis of Nonconvulsive Seizures in Critically Ill Patients
Ceribell announced the publication of a study in Neurology that highlights the clinical utility of its rapid EEG system for diagnosing nonconvulsive seizures in critically ill patients, showing improved diagnostic accuracy and speed.
2023-09
Ceribell
Ceribell Receives FDA 510(k) Clearance for Its Rapid EEG System for Use in the Emergency Department
Ceribell announced it has received FDA 510(k) clearance for its rapid EEG system, expanding its use to the emergency department for quick assessment of brain activity.
2023-07
Ceribell
Ceribell Announces Publication of Study Demonstrating the Impact of Its Rapid EEG System on Time to Treatment for Nonconvulsive Seizures
A study published in the Journal of Clinical Neurophysiology demonstrated that Ceribell's rapid EEG system significantly reduces the time to treatment for nonconvulsive seizures, improving patient outcomes.
2023-05
Healthcare IT News
Ceribell's Rapid EEG System Shows Promise in Detecting Delirium in ICU Patients
A recent article discusses how Ceribell's rapid EEG system is being explored for its potential in early detection and monitoring of delirium in intensive care unit patients, offering a new tool for critical care.
2023-04
Epilepsia
The Role of Rapid EEG in the Diagnosis and Management of Status Epilepticus
A peer-reviewed article in Epilepsia discusses the increasing role of rapid EEG technologies, such as Ceribell's system, in the timely diagnosis and effective management of status epilepticus.
2023-03
MedTech Dive
Ceribell's Point-of-Care EEG System Gains Traction in Critical Care Settings
MedTech Dive reports on the growing adoption of Ceribell's point-of-care EEG system in critical care environments, highlighting its ease of use and ability to provide immediate brain activity insights.
2023-02
Regulatory Affairs Professionals Society (RAPS)
FDA Grants Breakthrough Device Designation to Ceribell for Delirium Monitoring
Ceribell received Breakthrough Device Designation from the FDA for its technology aimed at monitoring delirium, recognizing its potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.
2022-11
Critical Care Medicine
Improving Neurological Monitoring in the ICU with Portable EEG
A publication in Critical Care Medicine explores the benefits of portable EEG devices, including Ceribell's system, for continuous neurological monitoring in the ICU, emphasizing its role in detecting subtle neurological changes.
2022-10

Videos

Product demos, reviews, and walkthroughs for Ceribell Delirium Monitor System.

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Frequently Asked Questions

The Ceribell Delirium Monitor System uses a machine learning model to analyze EEG signals to detect features indicative of delirium. It is intended to aid in the screening and monitoring of delirium in adult patients in critical care settings within hospitals. The system continuously analyzes EEG segments and alerts clinicians when patterns associated with delirium are detected.
The Ceribell Delirium Monitor System is a diagnostic tool and not a treatment device. It is intended to aid in screening and monitoring, and changes in patient condition detected by the device should be verified before interventions. It is only compatible with the Ceribell EEG Recorder and single-use Ceribell EEG patient headbands, and its output has not been tested on pediatric patients. The device does not replace professional medical judgment, diagnosis, or standard of care, and cannot be used as a substitute for real-time EEG monitoring by a trained expert.
The Ceribell Delirium Monitor System received FDA 510(k) clearance in December 2025, making it the first and only FDA-cleared system for delirium screening and monitoring. Additionally, the U.S. Centers for Medicare & Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) of up to $2,171 per eligible Medicare patient case for the system, effective October 1, 2026.
While traditional delirium assessments often rely on intermittent, labor-intensive bedside evaluations like the Confusion Assessment Method for the ICU (CAM-ICU) and the Intensive Care Delirium Screening Checklist (ICDSC), these methods can be inconsistent and unreliable due to factors like deep sedation or language barriers. The Ceribell system offers continuous EEG monitoring, which can provide more objective and timely insights compared to these traditional, static assessments.
The U.S. Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for the Ceribell Delirium Monitor System, providing up to $2,171 per eligible Medicare patient case. This add-on payment became effective on October 1, 2026, and is intended to facilitate broader access to the technology for critically ill patients.

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

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