Embrace2

JSON twin: https://www.healthaidb.com/software/embrace2.json

Company Name

Empatica

Product URL

https://www.empatica.com/embrace2

Company URL

https://www.empatica.com

Categories

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

Summary

Embrace2 is an FDA-cleared wrist-worn device designed to detect convulsive seizures and alert caregivers instantly, providing continuous safety and comfort for individuals with epilepsy.

Description

Embrace2 is a wearable medical device that monitors physiological signals to detect possible convulsive seizures. Upon detection, it sends immediate alerts to caregivers via its companion app, Alert, ensuring timely assistance. The device is FDA-cleared for adults and children aged 6 and up, offering over 48 hours of battery life and a quick 30-minute charge time. It features interchangeable bands for personalized comfort and is water-resistant up to 1 meter. Embrace2 is no longer available for new purchases, with Empatica transitioning to its next-generation device, EpiMonitor.

Api Available

yes

Certifications

• FDA 510(k) clearance
• CE Marking
• ISO/IEC 27001:2013
• ISO 14971:2019
• IEC 60601-1:2005/A1:2012
• IEC 60601-1-2:2014
• IEC 60601-1-6:2010 + AMD1:2013

Company Founding

2011

Company Offices

• United States
• Italy
• United Kingdom
• Germany
• France
• Denmark
• Sweden
• Belgium
• Luxembourg
• Austria

Compliance

• HIPAA
• GDPR
• ISO/IEC 27001:2013
• FDA 21 CFR Part 820
• ISO 14971:2019
• IEC 60601-1:2005/A1:2012
• IEC 60601-1-2:2014
• IEC 60601-1-6:2010 + AMD1:2013

Customers

Data Residency

US/EU regions

Data Standards

• FDA 510(k) clearance
• ISO/IEC 27001:2013
• ISO 14971:2019
• IEC 60601-1:2005/A1:2012
• IEC 60601-1-2:2014
• IEC 60601-1-6:2010 + AMD1:2013

Deployment Model

• SaaS

Features

• Seizure detection
• Real-time alerts
• Electrodermal Activity (EDA) monitoring
• Motion tracking
• Skin surface temperature measurement
• Rest and physical activity analysis
• Autonomic nervous system arousal monitoring
• Generalized tonic-clonic seizures (GTCS) detection
• 48+ hours battery life
• Water-resistant up to 1 meter
• Fast charging (1 hour 40 minutes)
• Internal memory for up to 14 hours of data storage
• Bluetooth connectivity
• FDA-cleared medical device
• Lightweight design (13 grams)
• Interchangeable bands
• Companion apps: Alert and Mate

Id

SW0568

Integration Partners

Integrations

• Alert App
• Mate App
• Empatica Health Monitoring Platform
• EpiMonitor
• Cloud API

Languages Supported

• English
• German
• French
• Spanish
• Italian
• Dutch
• Swedish
• Danish
• Finnish
• Norwegian
• Portuguese
• Greek
• Polish
• Czech
• Hungarian
• Romanian
• Bulgarian
• Croatian
• Slovak
• Slovenian

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• Consumer

Optional Modules

• Empatica Health Monitoring Platform
• EpiMonitor
• Cloud API integration

Os Platforms

• iOS
• Android

Pricing Details

Embrace2 is no longer available for new purchases. Existing users can continue their subscription services, including alerting. For those in the US or EU, Empatica offers a trade-in program to upgrade to EpiMonitor at a discounted rate.

Pricing Model

Subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0568

Product Name

Embrace2

Ratings

Regions Available

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

Related Urls

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

Release Year

""

Security Features

• Encryption
• Role-Based Access Control (RBAC)
• Single Sign-On (SSO)
• Audit logs
• Two-Factor Authentication (2FA)
• Data Loss Prevention (DLP)

Specialties

• Neurology
• Epilepsy

Support Channels

System Requirements

iOS 10-16, Android 11-13

Target Users

• Patients
• Caregivers
• Clinicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Embrace2",
  "company_name": "Empatica",
  "product_url": "https://www.empatica.com/embrace2",
  "company_url": "https://www.empatica.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0568",
  "summary": "Embrace2 is an FDA-cleared wrist-worn device designed to detect convulsive seizures and alert caregivers instantly, providing continuous safety and comfort for individuals with epilepsy.",
  "description": "Embrace2 is a wearable medical device that monitors physiological signals to detect possible convulsive seizures. Upon detection, it sends immediate alerts to caregivers via its companion app, Alert, ensuring timely assistance. The device is FDA-cleared for adults and children aged 6 and up, offering over 48 hours of battery life and a quick 30-minute charge time. It features interchangeable bands for personalized comfort and is water-resistant up to 1 meter. Embrace2 is no longer available for new purchases, with Empatica transitioning to its next-generation device, EpiMonitor.",
  "categories": [
    "clinical Care",
    "patient Facing",
    "diagnostic Support",
    "remote Monitoring",
    "Clinical",
    "Patient-facing",
    "Diagnostic",
    "Monitoring"
  ],
  "market_segment": [
    "Enterprise",
    "Consumer"
  ],
  "target_users": [
    "Patients",
    "Caregivers",
    "Clinicians"
  ],
  "specialties": [
    "Neurology",
    "Epilepsy"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "United Kingdom",
    "Germany",
    "France",
    "Denmark",
    "Sweden",
    "Belgium",
    "Luxembourg",
    "Austria",
    "Liechtenstein",
    "Ireland",
    "Spain",
    "Italy",
    "Netherlands",
    "Malta",
    "Finland"
  ],
  "languages_supported": [
    "English",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Dutch",
    "Swedish",
    "Danish",
    "Finnish",
    "Norwegian",
    "Portuguese",
    "Greek",
    "Polish",
    "Czech",
    "Hungarian",
    "Romanian",
    "Bulgarian",
    "Croatian",
    "Slovak",
    "Slovenian"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Embrace2 is no longer available for new purchases. Existing users can continue their subscription services, including alerting. For those in the US or EU, Empatica offers a trade-in program to upgrade to EpiMonitor at a discounted rate.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "Italy",
    "United Kingdom",
    "Germany",
    "France",
    "Denmark",
    "Sweden",
    "Belgium",
    "Luxembourg",
    "Austria"
  ],
  "company_founding": "2011",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "iOS",
    "Android"
  ],
  "features": [
    "Seizure detection",
    "Real-time alerts",
    "Electrodermal Activity (EDA) monitoring",
    "Motion tracking",
    "Skin surface temperature measurement",
    "Rest and physical activity analysis",
    "Autonomic nervous system arousal monitoring",
    "Generalized tonic-clonic seizures (GTCS) detection",
    "48+ hours battery life",
    "Water-resistant up to 1 meter",
    "Fast charging (1 hour 40 minutes)",
    "Internal memory for up to 14 hours of data storage",
    "Bluetooth connectivity",
    "FDA-cleared medical device",
    "Lightweight design (13 grams)",
    "Interchangeable bands",
    "Companion apps: Alert and Mate"
  ],
  "optional_modules": [
    "Empatica Health Monitoring Platform",
    "EpiMonitor",
    "Cloud API integration"
  ],
  "integrations": [
    "Alert App",
    "Mate App",
    "Empatica Health Monitoring Platform",
    "EpiMonitor",
    "Cloud API"
  ],
  "data_standards": [
    "FDA 510(k) clearance",
    "ISO/IEC 27001:2013",
    "ISO 14971:2019",
    "IEC 60601-1:2005/A1:2012",
    "IEC 60601-1-2:2014",
    "IEC 60601-1-6:2010 + AMD1:2013"
  ],
  "api_available": "yes",
  "system_requirements": "iOS 10-16, Android 11-13",
  "compliance": [
    "HIPAA",
    "GDPR",
    "ISO/IEC 27001:2013",
    "FDA 21 CFR Part 820",
    "ISO 14971:2019",
    "IEC 60601-1:2005/A1:2012",
    "IEC 60601-1-2:2014",
    "IEC 60601-1-6:2010 + AMD1:2013"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE Marking",
    "ISO/IEC 27001:2013",
    "ISO 14971:2019",
    "IEC 60601-1:2005/A1:2012",
    "IEC 60601-1-2:2014",
    "IEC 60601-1-6:2010 + AMD1:2013"
  ],
  "security_features": [
    "Encryption",
    "Role-Based Access Control (RBAC)",
    "Single Sign-On (SSO)",
    "Audit logs",
    "Two-Factor Authentication (2FA)",
    "Data Loss Prevention (DLP)"
  ],
  "privacy_features": [
    "Business Associate Agreement (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": "SW0568",
  "slug": "embrace2",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/embrace2.json"
  }
}