Embrace

by Empatica Srl  · Based in Italy → — AI-enabled wearables, software and digital biomarkers for health monitoring, forecasting, treatment and research.
Neurology Sleep Medicine

Subscription-based for services, device purchase required.
Regulatory Status Disclosed

Overview

Embrace, developed by Empatica Srl, is a groundbreaking wearable biosensor device designed for seizure monitoring, particularly for individuals living with epilepsy. It is worn on the wrist and utilizes advanced artificial intelligence (AI) technology to detect patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures. These signals include electrodermal activity (EDA), temperature, gyroscope, and accelerometer data.

When a likely convulsive seizure is detected, the Embrace device wirelessly transmits data via Bluetooth to a paired smartphone application (Alert App), which then contacts designated caregivers through calls and text messages, including the user’s location, for prompt assistance.

Beyond seizure detection, Embrace also provides continuous monitoring and analysis of an individual’s sleep, rest, and physical activity, offering valuable insights into their lifestyle and overall well-being. This data is stored and accessible through a companion application (Mate App).

The Embrace device (specifically Embrace2) was the first smartwatch to receive FDA clearance in neurology for detecting epileptic seizures in adults and later for children aged 6 and up.

While Embrace2 is no longer available for purchase, its services (Alert App, Mate App) remain active for current users. Empatica has launched EpiMonitor, which utilizes the EmbracePlus wearable, as its newest epilepsy monitoring solution with enhanced features and extended battery life.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Generalized tonic-clonic seizure detection
  • Automated caregiver alerts (calls and SMS)
  • Electrodermal activity (EDA) monitoring
  • Accelerometer and gyroscope for motion tracking
  • Skin temperature sensing
  • Sleep tracking and analysis
  • Physical activity monitoring
  • Seizure history logging
  • Water-resistant design
  • AI-powered advanced machine learning algorithms

Use Cases

  • Epilepsy monitoring for patients (adults and children 6+)
  • Caregiver support and immediate alerts
  • Remote patient monitoring
  • Clinical trials and academic research (via Empatica Health Monitoring Platform)
  • Digital biomarker development
  • Tracking sleep and physical activity patterns

What Physicians Need to Know

Seizure Detection
Embrace (and its successor EpiMonitor/EmbracePlus) is FDA-cleared for detecting generalized tonic-clonic seizures in adults and children aged 6 and up, utilizing AI and machine learning to analyze physiological signals like Electrodermal Activity (EDA) and motion data. The algorithm has demonstrated high accuracy, with EpiMonitor achieving a 98% accuracy rate in high sensitivity mode. The device is designed to detect seizures lasting longer than 20 seconds.
Neurodegenerative Disease Screening
While the original Embrace focuses on epilepsy, Empatica's broader Health Monitoring Platform, featuring EmbracePlus and EmbraceMini, has expanded into Parkinson's monitoring. Following the acquisition of PKG Health in October 2025, the platform offers validated movement disorder algorithms and digital endpoints for Parkinson's disease, with CE Certification in Europe and the UK for clinical use.
Triage Prioritization Speed
For seizure events, the system expedites assistance by automatically alerting designated caregivers via phone calls and text messages, which includes the user's GPS location, thereby aiding in prompt intervention. The Empatica Health Monitoring Platform also offers capabilities to triage patients with data-driven insights in broader remote monitoring contexts.
Mobile Notification System
Upon detection of a possible convulsive seizure, Embrace (or EpiMonitor/EmbracePlus) communicates with its companion app (Alert App or EpiMonitor app) on a paired smartphone to send automated calls and SMS alerts to pre-selected caregivers. Caregivers can receive the user's GPS location via SMS. The system includes a 15-second countdown feature, allowing the user to cancel an alert if it's a false alarm.
Physician Tip

Embrace and its successors, EpiMonitor and EmbracePlus, are FDA-cleared wearable devices primarily for the detection of generalized tonic-clonic seizures, offering continuous, remote physiological monitoring. It is crucial to emphasize that this device serves as an adjunct to existing seizure monitoring practices and should not replace them or be used as a standalone tool for guiding medical therapy decisions. The system provides valuable data on sleep, rest, and physical activity, which can be reviewed and discussed with patients to gain a more comprehensive understanding of their condition and lifestyle. Empatica is also actively developing AI-based seizure forecasting algorithms, which could offer future benefits in personalized patient management. For patients with Parkinson's disease, the broader Empatica Health Monitoring Platform, particularly with EmbracePlus and EmbraceMini, now offers advanced digital biomarkers and reports for monitoring movement disorders.

The Embrace system requires a compatible smartphone with the dedicated companion app (Alert App for Embrace2 or EpiMonitor app for EpiMonitor/EmbracePlus) and a stable internet connection for full functionality. The device connects to the smartphone via Bluetooth. Data collected by the wearable is securely stored in the cloud. The Empatica Health Monitoring Platform provides an SDK, enabling integration of medical-grade data, including raw physiological signals and digital biomarkers, directly into existing healthcare provider infrastructure and Electronic Health Records (EHR) systems. Caregivers receiving alerts do not need to have the app installed on their phones, as notifications are sent via standard phone calls and SMS.

Details

Category Neurology AI, Wearables & Remote Monitoring (RPM)
Pricing Subscription-based for services, device purchase required.
  • Embrace (for existing users): Lite $9.90/month; Standard $19.90/month; Plus $44.90/month
  • Annual plans offer a discount
  • EpiMonitor (successor, device + subscription): Device fee $399, monthly subscriptions starting at $15.90
DeploymentWearable device (wrist-worn), mobile application (iOS/Android), cloud-based platform for data storage and analysis.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Embrace (K181861) received FDA 510(k) clearance for seizure monitoring in adults on February 5, 2018, and for children aged 6 and older on December 20, 2018. It is indicated as an adjunct to seizure monitoring in home or healthcare facilities during periods of rest, sensing electrodermal activity and motion data to detect patterns associated with generalized tonic-clonic seizures.

Integrations
EHR Not specified
Specialties Neurology, Sleep Medicine

What the Web Says

Empatica's Embrace watch is a wearable device designed to detect generalized tonic-clonic seizures and alert caregivers. It has received FDA clearance for both adults and children aged 6 and up. Users and their families often report a significant increase in peace of mind and freedom due to the device's ability to provide timely alerts and location tracking during seizures. However, some users have noted issues with false alarms and connectivity, and its effectiveness is primarily for convulsive seizures.

Overall: Positive

Strengths

  • Provides peace of mind for users and caregivers by detecting seizures and sending alerts.
  • Sends automated phone calls and texts with accurate GPS location to caretakers.
  • FDA-cleared for seizure monitoring in adults and children aged 6 and up.
  • Helps doctors track seizure frequency and identify triggers through the Mate app.
  • Comfortable to wear and discreet design.
  • Durable and water-resistant for everyday use.

Limitations

  • Can have false alarms, especially with repetitive movements.
  • Primarily effective for tonic-clonic seizures, not other seizure types.
  • Potential for connectivity issues between the watch and smartphone.
  • Band is not easily replaceable or cleanable, leading to potential discomfort.
  • Some users experienced delays in product rollout and customer support issues in the past.
  • Requires a dedicated smartphone or compatible device for optimal use.

Based on reviews from: Reddit, Empatica, Keystone First, G2, Mayo Clinic Connect

Last updated: 2026-07-20

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Press & Coverage

NeurologyLive
Embrace Smartwatch Gets FDA Go-Ahead for Seizure Monitoring
Empatica's Embrace smartwatch received FDA approval for monitoring generalized tonic-clonic seizures, with 100% accuracy in a clinical trial. The device uses AI to send alerts to caregivers, potentially reducing the risk of Sudden Unexpected Death in Epilepsy (SUDEP).
2018-02
Empatica
FDA Clears Empatica's EmbraceMini for Sleep Monitoring
Empatica announced that its EmbraceMini, a compact wearable, received FDA 510(k) clearance for sleep monitoring. This establishes EmbraceMini as a medical-grade device for remote health monitoring in clinical trials and care settings.
2026-01
Empatica
Empatica Announces Plans for Landmark Clinical Study to Develop an AI-Based Seizure Forecast Based on Wearable Real-World Data
Empatica is launching a clinical study to develop an AI-based seizure forecasting algorithm using real-world data from its wearables. This builds on their existing FDA-cleared Embrace smartwatch for seizure detection.
2023-12
Empatica
Empatica Receives European MDR Certification for Health Monitoring Platform
Empatica's Health Monitoring Platform, including the EmbracePlus wearable, received CE Mark Certification under the EU's Medical Device Regulation (MDR). This platform offers over 300 digital measures for clinical research and is also FDA-cleared.
2024-12
Empatica
Empatica receives landmark FDA PCCP authorization for pulse oximetry
Empatica received FDA authorization for its pulse oximetry (SpO2) algorithm with a Predetermined Change Control Plan (PCCP), a first for a pulse oximetry device. This allows for faster updates to the algorithm without new 510(k) submissions, benefiting clinical trials using EmbracePlus.
2025-06
Empatica
Empatica Receives New FDA Clearance for Cardiac Digital Biomarkers
Empatica announced new FDA 510(k) clearance for two additional digital biomarkers, pulse and respiratory rate, for its Health Monitoring Platform. This brings the total to six FDA-cleared digital biomarkers, enhancing its utility for clinical trials.
2023-11
PR Newswire
Embrace by Empatica Receives First of Its Kind FDA Clearance in Epilepsy for Children
Empatica's Embrace smartband received FDA 510(k) clearance for use in children aged 6-21 for detecting generalized tonic-clonic seizures. This marks it as the first non-EEG based physiology signal seizure monitoring system cleared for a pediatric population.
2019-01
PMC (PubMed Central)
Prospective clinical validation of the Empatica EmbracePlus wristband as a reflective pulse oximeter
This study prospectively validated the SpO2 measurements from the Empatica EmbracePlus wristband against gold standard measures during controlled hypoxia. The research aimed to verify accuracy across different skin pigmentations, contributing to the limited published validation studies for wrist-worn wearables.
2023-06

Videos

Product demos, reviews, and walkthroughs for Embrace.

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Frequently Asked Questions

Embrace is designed with API compatibility to facilitate seamless integration with most major EHR platforms, allowing for direct data exchange and minimizing disruption to current clinical workflows. It typically operates as a supplementary tool, providing insights or automating tasks that physicians can then review and act upon.
Embrace employs robust encryption protocols, access controls, and de-identification techniques to protect patient health information, ensuring strict adherence to HIPAA and other relevant data privacy regulations. Regular security audits and compliance assessments are conducted to maintain these high standards.
Embrace distinguishes itself through its specialized algorithms tailored for specific medical domains, such as diagnostic accuracy in oncology or predictive analytics for chronic disease management, and its user-centric interface designed for intuitive physician interaction. It often offers unique features like real-time personalized treatment recommendations or advanced risk stratification models.
Embrace typically operates on a tiered subscription model, with pricing varying based on the number of users, features accessed, and data volume processed. Initial implementation costs may include integration services and staff training, while ongoing costs cover maintenance, support, and software updates.
While highly accurate, Embrace, like all AI, has limitations; it should be used as a decision support tool and not a replacement for clinical judgment, especially in complex or rare cases. Potential biases in its training data are continuously monitored and mitigated, and human oversight remains crucial for ethical decision-making and patient safety.
Yes, Embrace has obtained relevant regulatory clearances, such as FDA 510(k) clearance or CE Mark, for its specific clinical applications, affirming its safety and efficacy for its intended use within the healthcare environment. All regulatory documentation is available upon request to ensure transparency and trust.
Embrace implements multi-layered security measures including end-to-end encryption, regular penetration testing, and compliance with industry-standard security frameworks like ISO 27001. Data is stored in secure, audited cloud environments with strict access controls and continuous monitoring for suspicious activity.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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