EpiMonitor

JSON twin: https://www.healthaidb.com/software/epimonitor.json

Company Name

Empatica

Product URL

https://www.empatica.com/epimonitor

Company URL

https://www.empatica.com

Categories

• clinical Care
• patient Facing
• diagnostic Support
• remote Monitoring
• Clinical
• Diagnostic
• Monitoring

Summary

EpiMonitor by Empatica is an FDA-cleared wearable device designed to detect generalized tonic-clonic seizures and provide continuous health monitoring for individuals with epilepsy.

Description

EpiMonitor is a medical-grade wearable solution that combines the EmbracePlus smartwatch with a companion smartphone app to monitor health data, detect potential seizures, and alert caregivers promptly. It offers features such as automated seizure detection with 98% accuracy, up to 7 days of battery life, sleep and activity tracking, and a seizure diary for comprehensive health management.

Api Available

yes

Certifications

• FDA 510(k)
• CE MDR
• ISO 13485:2021
• ISO/IEC 27001:2013

Company Founding

2014

Company Offices

• United States
• Italy
• Germany
• France
• United Kingdom
• Denmark
• Sweden
• Belgium
• Luxembourg
• Austria
• Liechtenstein
• Ireland
• Netherlands
• Malta
• Finland

Compliance

• FDA 510(k)
• CE MDR
• ISO 13485:2021
• ISO/IEC 27001:2013
• HIPAA
• GDPR

Customers

Data Residency

US and EU regions

Data Standards

• HL7
• FHIR
• DICOM

Deployment Model

• SaaS

Features

• FDA-cleared seizure detection with 98% accuracy
• Automated alerts to caregivers via call and SMS
• Self-triggered alerts for user-initiated assistance
• Seizure, sleep, and activity diaries
• Sleep and activity tracking with detailed reports
• Up to 7 days of battery life
• Adjustable sensing precision to reduce false alerts
• User-friendly mobile app available in 8 languages

Id

SW0254

Integration Partners

Integrations

• Empatica Cloud API
• Clinical trial management software

Languages Supported

• English
• Spanish
• French
• Italian
• German
• Dutch
• Danish
• Swedish

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB
• Consumer

Optional Modules

• Seizure forecasting study participation

Os Platforms

• iOS
• Android

Pricing Details

One-time device fee of $399; monthly subscriptions starting at $15.90; 30-day money-back guarantee; 1-year warranty.

Pricing Model

Subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0254

Product Name

EpiMonitor

Ratings

Regions Available

• United States
• Germany
• France
• Italy
• Spain
• Denmark
• Sweden
• Belgium
• Luxembourg
• Austria
• Liechtenstein
• Ireland
• Netherlands
• Malta
• Finland

Related Urls

• https://apps.apple.com/us/app/epimonitor-by-empatica/id1669234452
• https://www.businesswire.com/news/home/20240227351574/en/Empatica-Reveals-Next-Generation-FDA-Cleared-Epilepsy-Watch-and-Launches-AI-Seizure-Forecasting-Study
• https://www.afp.com/index.php/en/infos/empatica-achieves-ce-mdr-certification-epimonitor-bringing-round-clock-epilepsy-monitoring
• https://www.epilepsyalarms.co.uk/product/epimonitor/
• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• RBAC
• Audit logs
• 2FA
• DLP

Specialties

• Neurology
• Epilepsy Care

Support Channels

System Requirements

Bluetooth 5.0 or higher, iOS 16 or higher, Android 12 or higher

Target Users

• Patients
• Caregivers
• Clinicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "EpiMonitor",
  "company_name": "Empatica",
  "product_url": "https://www.empatica.com/epimonitor",
  "company_url": "https://www.empatica.com",
  "related_urls": [
    "https://apps.apple.com/us/app/epimonitor-by-empatica/id1669234452",
    "https://www.businesswire.com/news/home/20240227351574/en/Empatica-Reveals-Next-Generation-FDA-Cleared-Epilepsy-Watch-and-Launches-AI-Seizure-Forecasting-Study",
    "https://www.afp.com/index.php/en/infos/empatica-achieves-ce-mdr-certification-epimonitor-bringing-round-clock-epilepsy-monitoring",
    "https://www.epilepsyalarms.co.uk/product/epimonitor/",
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0254",
  "summary": "EpiMonitor by Empatica is an FDA-cleared wearable device designed to detect generalized tonic-clonic seizures and provide continuous health monitoring for individuals with epilepsy.",
  "description": "EpiMonitor is a medical-grade wearable solution that combines the EmbracePlus smartwatch with a companion smartphone app to monitor health data, detect potential seizures, and alert caregivers promptly. It offers features such as automated seizure detection with 98% accuracy, up to 7 days of battery life, sleep and activity tracking, and a seizure diary for comprehensive health management.",
  "categories": [
    "clinical Care",
    "patient Facing",
    "diagnostic Support",
    "remote Monitoring",
    "Clinical",
    "Patient-facing",
    "Diagnostic",
    "Monitoring"
  ],
  "market_segment": [
    "Enterprise",
    "SMB",
    "Consumer"
  ],
  "target_users": [
    "Patients",
    "Caregivers",
    "Clinicians"
  ],
  "specialties": [
    "Neurology",
    "Epilepsy Care"
  ],
  "regions_available": [
    "United States",
    "Germany",
    "France",
    "Italy",
    "Spain",
    "Denmark",
    "Sweden",
    "Belgium",
    "Luxembourg",
    "Austria",
    "Liechtenstein",
    "Ireland",
    "Netherlands",
    "Malta",
    "Finland"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "Italian",
    "German",
    "Dutch",
    "Danish",
    "Swedish"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "One-time device fee of $399; monthly subscriptions starting at $15.90; 30-day money-back guarantee; 1-year warranty.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "Italy",
    "Germany",
    "France",
    "United Kingdom",
    "Denmark",
    "Sweden",
    "Belgium",
    "Luxembourg",
    "Austria",
    "Liechtenstein",
    "Ireland",
    "Netherlands",
    "Malta",
    "Finland"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "iOS",
    "Android"
  ],
  "features": [
    "FDA-cleared seizure detection with 98% accuracy",
    "Automated alerts to caregivers via call and SMS",
    "Self-triggered alerts for user-initiated assistance",
    "Seizure, sleep, and activity diaries",
    "Sleep and activity tracking with detailed reports",
    "Up to 7 days of battery life",
    "Adjustable sensing precision to reduce false alerts",
    "User-friendly mobile app available in 8 languages"
  ],
  "optional_modules": [
    "Seizure forecasting study participation"
  ],
  "integrations": [
    "Empatica Cloud API",
    "Clinical trial management software"
  ],
  "data_standards": [
    "HL7",
    "FHIR",
    "DICOM"
  ],
  "api_available": "yes",
  "system_requirements": "Bluetooth 5.0 or higher, iOS 16 or higher, Android 12 or higher",
  "compliance": [
    "FDA 510(k)",
    "CE MDR",
    "ISO 13485:2021",
    "ISO/IEC 27001:2013",
    "HIPAA",
    "GDPR"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE MDR",
    "ISO 13485:2021",
    "ISO/IEC 27001:2013"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US and EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0254",
  "slug": "epimonitor",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/epimonitor.json"
  }
}