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

Contact for pricing
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
Utilizes the Clarity AI algorithm for real-time interpretation of EEG signals, detecting seizure activity and patterns indicative of delirium. The algorithm monitors seizure activity within a 5-minute interval for seizure burden and continuously analyzes EEG segments for delirium patterns.
Seizure Detection
Provides rapid, point-of-care detection and continuous monitoring of nonconvulsive seizures and electrographic status epilepticus in adults, neonates, and preterm infants, with real-time alerts. The Clarity AI algorithm continuously monitors for seizures, analyzing data every 10 seconds and providing bedside alerts within minutes if sustained seizure activity is detected.
Large Vessel Occlusion Detection
Received FDA Breakthrough Device Designation for its AI-powered solution to aid in the early detection and monitoring of Large Vessel Occlusion (LVO) strokes in hospitalized patients, utilizing the existing EEG hardware and an AI algorithm to interpret brain signals.
Triage Prioritization Speed
Enables rapid EEG setup within minutes by any trained healthcare provider, without requiring an EEG technician, significantly expediting EEG acquisition and supporting faster triage and diagnosis in acute care settings. This can reduce the median time to EEG acquisition.
Mobile Notification System
Offers a comprehensive mobile experience with real-time alerts and remote access to full EEG data via a cloud-based portal, accessible anywhere, anytime, on any device. Custom notifications can be tailored to schedules and preferences, including on-screen displays and optional email messages.
Physician Tip

The Ceribell Delirium Monitor System serves as a crucial point-of-care EEG tool for rapid assessment and continuous monitoring in acute care settings. Its AI-powered Clarity algorithm facilitates real-time detection of nonconvulsive seizures, electrographic status epilepticus, and delirium patterns, allowing for quicker diagnosis and intervention. The system's ease of use by non-specialists and remote access capabilities for neurologists can significantly streamline workflows and improve patient outcomes by reducing delays in treatment. Additionally, its FDA Breakthrough Device Designation for LVO stroke detection highlights its expanding utility in critical neurological emergencies.

The Ceribell system features a cloud-based portal for remote access to real-time EEG data, enhancing collaboration among care teams. It supports EMR integration, which helps reduce duplicate data entry, speeds up billing processes, and provides bedside teams with more time for direct patient care by centralizing patient records.

Details

Category Neurology AI, Triage & ER/ICU AI
Pricing Contact for pricing Contact Ceribell for detailed pricing information on subscriptions and packages.
DeploymentCloud-based portal with bedside hardware (recorder)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Ceribell Delirium Monitor System (K251936) is FDA-cleared to analyze features associated with diffuse slowing electroencephalogram (EEG) patterns that may be indicative of delirium. It is intended to aid in the screening and monitoring of delirium with clinical assessments in adult patients in critical care settings within hospitals.

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

What the Web Says

The Ceribell Delirium Monitor System is a portable EEG device designed for rapid brain activity monitoring to aid in the detection of delirium. It's praised for its ease of use and quick setup, making it suitable for various clinical settings, including the ICU and emergency department. The system aims to provide objective data to support clinical judgment in identifying delirium, a condition often underdiagnosed.

Overall: Positive

Strengths

  • Extremely easy and quick to set up (under 5 minutes)
  • Portable and compact, suitable for bedside use
  • Provides objective EEG data for delirium detection
  • User-friendly interface and intuitive design
  • Can be used by non-EEG specialists
  • Aids in early detection of delirium, potentially improving patient outcomes

Limitations

  • Cost of the device and recurring electrode costs
  • Requires proper training for interpretation, though simplified
  • May not replace full neurological assessment
  • Limited long-term data on impact on patient outcomes (as a newer technology)
  • Potential for artifact if not applied correctly
  • Integration with existing hospital IT systems might require effort

Based on reviews from: Ceribell.com, Physician reviews (various medical forums and articles), Healthcare IT publications, Reddit (medical subreddits), G2 (no specific reviews found for this product), Capterra (no specific reviews found for this product)

Last updated: 2026-07-18

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Press & Coverage

Medical Device and Diagnostic Industry
FDA Clears Ceribell's Delirium Monitoring Solution
Ceribell received FDA 510(k) clearance for its delirium monitoring solution, making it the first such device cleared by the agency. This expands the Ceribell System as an AI-powered brain monitoring platform for critically ill patients, aiding in diagnosing those at risk for seizures and delirium.
2025-12
Ceribell, Inc. (Press Release)
Ceribell Receives FDA 510(k) Clearance for First-of-its-Kind Delirium Monitoring Solution
Ceribell announced FDA 510(k) clearance for its delirium monitoring solution, the first and only FDA-cleared device for delirium screening and monitoring. This AI-powered system continuously analyzes EEG segments to detect patterns associated with delirium, supporting timely evaluation and continuous monitoring.
2025-12
Medgadget
FDA Clears Ceribell's AI-Powered EEG as First Device for Continuous Delirium Monitoring
Ceribell's AI-powered EEG system received FDA 510(k) clearance for continuous delirium monitoring, expanding its platform beyond seizure detection. This marks the first objective, real-time monitoring tool for delirium, a condition often missed by subjective assessments.
2025-12
Healio
FDA grants 510(k) clearance to AI-powered delirium screening device
The FDA granted 510(k) clearance to Ceribell's proprietary delirium monitoring solution, making it the first and only such device to receive FDA clearance. This AI-powered device provides a reliable method for screening and tracking delirium in hospitalized patients.
2025-12
BioSpace
Ceribell Announces New Critical Care Medicine Publication Reinforcing Link Between Seizure Burden Measured by Clarity AI Algorithm and Neurological Outcomes
A new publication in Critical Care Medicine reinforces the link between seizure burden, measured by Ceribell's Clarity AI algorithm, and neurological outcomes. The Ceribell System is FDA-cleared for detecting seizure and delirium in ICUs and emergency rooms.
2026-06
Ceribell, Inc. (Press Release)
Ceribell Receives FDA Breakthrough Device Designation for LVO Stroke Detection and Monitoring Solution
Ceribell received FDA Breakthrough Device Designation for its LVO Stroke Detection and Monitoring Solution. The Ceribell System is already FDA-cleared for detecting seizure and delirium in critical care settings.
2026-01
SEC Filing
Form 8-K for Ceribell INC filed 12/09/2025
Ceribell, Inc. filed an 8-K announcing that the U.S. Food and Drug Administration granted 510(k) clearance for Ceribell's proprietary delirium screening and monitoring solution. This clearance follows a Breakthrough Device Designation in 2022.
2025-12
PR Newswire
Ceribell Receives FDA Breakthrough Device Designation for Delirium Indication
Ceribell announced it received Breakthrough Device Designation for its delirium indication from the FDA in 2022. This designation recognizes Ceribell's point-of-care EEG as a first-of-its-kind technology for delirium detection.
2022-09

Videos

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

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Frequently Asked Questions

The Ceribell Delirium Monitor System utilizes AI-powered algorithms to continuously analyze EEG segments and detect patterns associated with delirium. This provides real-time, objective neurological insights at the bedside, notifying clinicians when concerning activity appears to support more timely evaluation and continuous monitoring.
The system is FDA-cleared for screening and monitoring delirium in adult patients in critical care settings within hospitals, including intensive care units (ICUs) and emergency rooms. It is designed for short-term clinical use and aids in the assessment of delirium in conjunction with clinical evaluations.
The Ceribell Delirium Monitor System has received FDA 510(k) clearance as the first and only FDA-cleared delirium screening and monitoring device. Ceribell also holds FedRAMP High authorization, signifying adherence to rigorous government cybersecurity standards for protecting sensitive patient health information in its cloud-based portal.
Unlike intermittent, subjective bedside assessments, Ceribell provides continuous, objective EEG monitoring for delirium, including hypoactive forms often missed. While traditional EEG is often cumbersome and requires specialists, Ceribell offers a portable, rapid-response system that can be set up quickly by various healthcare providers.
While specific pricing is not publicly disclosed, Ceribell has submitted a New Technology Add-on Payment (NTAP) application to the Centers for Medicare and Medicaid Services (CMS) for this new indication, aiming to support hospital reimbursement and broader adoption. Studies suggest that rapid EEG systems like Ceribell may lead to cost savings by potentially reducing ICU length of stay and preventing unnecessary treatments.
The system is intended as an aid in screening and monitoring delirium and is not a standalone diagnostic tool; changes detected by the device should be clinically verified. It is not intended to replace standard clinical EEG or comprehensive neurological evaluation, and interpretation of EEG data can be affected by artifacts or signal noise.

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

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