EpiMonitor
Overview
EpiMonitor by Empatica is an FDA-cleared wearable medical device system designed for comprehensive epilepsy monitoring and seizure detection. It consists of the EmbracePlus smartwatch and a companion mobile application for iOS and Android. The system provides automated seizure alerts, sending calls and SMS messages with the user’s location to designated caregivers when a possible generalized tonic-clonic seizure is detected.
Beyond real-time alerts, EpiMonitor offers a user-friendly digital diary to track seizure events, triggers, and symptoms, which can be easily shared with healthcare providers. It also includes advanced features for tracking sleep quality and daily activity metrics, helping users and their doctors identify patterns and better manage their condition.
The device is prescription-only in the US and is cleared for use in adults and children aged 6 and up. It is important to note that EpiMonitor is a medical device for epilepsy monitoring and *not* a physician directory tool.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated seizure alerts (call and SMS with location) to caregivers
- Self-triggered alerts for manual caregiver notification
- Comprehensive digital seizure diary to log events, triggers, and symptoms
- Accurate sleep tracking with advanced metrics
- Daily activity tracking
- Adjustable sensing precision for seizure detection
- Up to 7 days of battery life for the EmbracePlus smartwatch
- Ability to export seizure, sleep, and activity reports for physicians
- False alarm cancellation feature
Use Cases
- Continuous epilepsy monitoring for individuals aged 6 and up
- Real-time seizure detection and caregiver notification
- Personalized epilepsy management through data tracking and insights
- Facilitating communication between patients and healthcare providers
- Supporting independence and peace of mind for individuals with epilepsy and their families
- Data collection for clinical research studies (as part of Empatica Health Monitoring Platform)
What Physicians Need to Know
EpiMonitor is an FDA-cleared and CE-certified prescription-only medical device in the US, indicated as an adjunct for generalized tonic-clonic seizure monitoring in adults and children aged 6 and up. It should supplement, not replace, existing seizure management practices and should not be used for medical or diagnostic decisions. The system provides a comprehensive seizure, sleep, and activity diary that can be exported as a PDF for review and discussion with healthcare providers, aiding in identifying trends and optimizing epilepsy management. Empatica is also conducting a study to develop a seizure forecasting algorithm, in which EpiMonitor users can participate.
The EpiMonitor system comprises the EmbracePlus wearable watch and a dedicated EpiMonitor mobile application, compatible with iOS and Android smartphones. For functionality, the EmbracePlus watch requires a Bluetooth connection to the user's smartphone (within 5 meters/15 feet), and the smartphone needs an active internet connection (Wi-Fi or cellular) to transmit data to the Empatica Cloud and trigger caregiver alerts. While it provides exportable PDF reports for sharing with clinicians, there is no explicit mention of direct integration with Electronic Medical Records (EMR) or other third-party neurology/neuroimaging platforms.
Details
| Category | Neurology AI, Wearables & Remote Monitoring (RPM) |
| Pricing |
Paid subscription with device purchase
|
| Deployment | Wearable device (EmbracePlus smartwatch) paired with a smartphone app (iOS/Android) and cloud-based data infrastructure. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated EpiMonitor (K250515) received FDA clearance on June 19, 2025, as a prescription-only medical device system intended as an adjunct to seizure monitoring in adults and children aged 6 and up, detecting patterns associated with generalized tonic-clonic seizures. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurology, Sleep Medicine |
What the Web Says
EpiMonitor by Empatica is an FDA-cleared wearable device and app system designed for epilepsy monitoring, detecting possible convulsive seizures, and tracking related health data. It aims to provide peace of mind for users and caregivers by sending automated alerts. While it offers features like a seizure diary, sleep and activity tracking, and a long battery life, user reviews indicate a mixed experience, with significant concerns regarding false alarms, connectivity issues, and the overall cost and subscription model.
Overall: MixedStrengths
- FDA-cleared for seizure detection in adults and children aged six and above.
- Long battery life (up to 7 days) and quick charging.
- Automated and manual real-time seizure alerts for caregivers via phone calls and SMS.
- Comprehensive epilepsy and seizure diary, including sleep and activity tracking.
- Improved seizure alert capabilities and fewer false alarms compared to its predecessor (Embrace2).
- Adjustable alert sensitivity controls to reduce false alarms.
Limitations
- Frequent false alarms, often triggered by everyday movements.
- Connectivity issues, with the device often disconnecting from Bluetooth.
- Requires the patient's phone to be in close proximity, making it impractical for children without phones or for independent movement.
- High cost of the device and expensive subscription fees, with essential features locked behind higher tiers.
- Poor app functionality, including difficulty navigating account settings, inaccurate sleep data, and a non-user-friendly interface.
- Customer support and availability are reported to be excruciating.
Based on reviews from: Apple App Store, Reddit, Epilepsy Action, Google Play Store
Last updated: 2026-07-21
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