ClarityPro AI

JSON twin: https://www.healthaidb.com/software/claritypro-ai.json

Company Name

Ceribell

Product URL

https://ceribell.com/product/claritypro/

Company URL

https://ceribell.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• neurology
• acute Care Management
• Clinical
• Diagnostic
• Acute Care

Summary

ClarityPro AI by Ceribell is an AI-driven EEG diagnostic system designed for rapid detection and monitoring of electrographic status epilepticus in critically ill patients, enhancing timely and informed neurological care decisions.

Description

ClarityPro AI is an advanced machine-learning algorithm integrated into Ceribell's portable EEG system, providing continuous, real-time monitoring and analysis of EEG waveforms to detect and diagnose electrographic status epilepticus (ESE). It offers bedside alerts, seizure burden displays, and medication response monitoring, facilitating prompt and precise treatment decisions in acute care settings.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• FDA Breakthrough Device Designation
• CMS New Technology Add-on Payment (NTAP)
• FedRAMP High authorization
• FDA clearance for pediatric patients aged 1 and older

Company Founding

2017

Company Offices

• United States

Compliance

• FDA 510(k) clearance
• FDA Breakthrough Device Designation
• CMS New Technology Add-on Payment (NTAP)
• FedRAMP High authorization
• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001

Customers

Data Residency

US/EU regions

Data Standards

• EEG data
• Seizure burden data
• Medication data

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Real-time EEG diagnostics
• Continuous EEG monitoring
• Automatic detection of suspected status epilepticus
• Diagnosis of electrographic status epilepticus
• Seizure burden estimation
• Medication effectiveness monitoring
• Seizure burden display with pre-annotations
• Instantaneous bedside alerts for status epilepticus
• Cloud-based AI algorithm
• 24/7 continuous EEG monitoring and alerts
• Seizure burden display with pre-annotations to support efficient EEG interpretation
• Real-time medication effectiveness monitoring
• Intuitive medication response monitoring
• FDA-cleared instantaneous bedside alert diagnosing electrographic status epilepticus
• Continuous EEG monitoring and seizure burden display
• Easily annotate medications at the bedside with just a touch
• Intuitive medication response monitoring can enable treatment optimization in real-time

Id

SW0351

Integration Partners

Integrations

• Ceribell EEG system
• EEG headbands
• EEG Portal

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• EEG Portal
• ClarityPro AI algorithm

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Enterprise_Quote

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0351

Product Name

ClarityPro AI

Ratings

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

""

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP

Specialties

• Neurology
• Critical Care
• Emergency Medicine

Support Channels

System Requirements

Ceribell EEG system, EEG headbands

Target Users

• Clinicians
• Neurologists
• Intensive Care Unit (ICU) Staff
• Emergency Department (ED) Staff

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "ClarityPro AI",
  "company_name": "Ceribell",
  "product_url": "https://ceribell.com/product/claritypro/",
  "company_url": "https://ceribell.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0351",
  "summary": "ClarityPro AI by Ceribell is an AI-driven EEG diagnostic system designed for rapid detection and monitoring of electrographic status epilepticus in critically ill patients, enhancing timely and informed neurological care decisions.",
  "description": "ClarityPro AI is an advanced machine-learning algorithm integrated into Ceribell's portable EEG system, providing continuous, real-time monitoring and analysis of EEG waveforms to detect and diagnose electrographic status epilepticus (ESE). It offers bedside alerts, seizure burden displays, and medication response monitoring, facilitating prompt and precise treatment decisions in acute care settings.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "neurology",
    "acute Care Management",
    "Clinical",
    "Diagnostic",
    "Patient-facing",
    "Neurology",
    "Acute Care"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Neurologists",
    "Intensive Care Unit (ICU) Staff",
    "Emergency Department (ED) Staff"
  ],
  "specialties": [
    "Neurology",
    "Critical Care",
    "Emergency Medicine"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Enterprise_Quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Real-time EEG diagnostics",
    "Continuous EEG monitoring",
    "Automatic detection of suspected status epilepticus",
    "Diagnosis of electrographic status epilepticus",
    "Seizure burden estimation",
    "Medication effectiveness monitoring",
    "Seizure burden display with pre-annotations",
    "Instantaneous bedside alerts for status epilepticus",
    "Cloud-based AI algorithm",
    "24/7 continuous EEG monitoring and alerts",
    "Seizure burden display with pre-annotations to support efficient EEG interpretation",
    "Real-time medication effectiveness monitoring",
    "Intuitive medication response monitoring",
    "FDA-cleared instantaneous bedside alert diagnosing electrographic status epilepticus",
    "Continuous EEG monitoring and seizure burden display",
    "Easily annotate medications at the bedside with just a touch",
    "Intuitive medication response monitoring can enable treatment optimization in real-time"
  ],
  "optional_modules": [
    "EEG Portal",
    "ClarityPro AI algorithm"
  ],
  "integrations": [
    "Ceribell EEG system",
    "EEG headbands",
    "EEG Portal"
  ],
  "data_standards": [
    "EEG data",
    "Seizure burden data",
    "Medication data"
  ],
  "api_available": "unknown",
  "system_requirements": "Ceribell EEG system, EEG headbands",
  "compliance": [
    "FDA 510(k) clearance",
    "FDA Breakthrough Device Designation",
    "CMS New Technology Add-on Payment (NTAP)",
    "FedRAMP High authorization",
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "FDA Breakthrough Device Designation",
    "CMS New Technology Add-on Payment (NTAP)",
    "FedRAMP High authorization",
    "FDA clearance for pediatric patients aged 1 and older"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "\"\"",
  "integration_partners": [],
  "id": "SW0351",
  "slug": "claritypro-ai",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/claritypro-ai.json"
  }
}