General
What is EpiMonitor?
EpiMonitor is an FDA-cleared and CE-certified epilepsy monitoring system designed to detect generalized tonic-clonic seizure events (GTCs). It consists of the EmbracePlus watch and a companion smartphone app. The EmbracePlus watch continuously reads physiological data from the surface of the skin – electrodermal activity, skin temperature, and motion, and runs a real-time detection algorithm examining patterns in the input data. When the algorithm detects a likely GTC seizure, it communicates wirelessly through the “EpiMonitor” app on a paired smartphone. The EpiMonitor app initiates a phone call and a text message to one or more designated caregivers.
Who is EpiMonitor for?
EpiMonitor has been FDA-cleared and CE-certified for adults and children ages 6 and up. EpiMonitor is designed to detect unusual patterns associated with generalized tonic-clonic seizures lasting 20 seconds or longer.
Is EpiMonitor suitable for children?
Yes, EpiMonitor is FDA-cleared in the US and CE MDR Certified in Europe for children ages 6 and up. The EmbracePlus device comes with an adjustable stretchable band in three different colors and two sizes, including an option for smaller wrists. If your child is younger than 6 years old, please consult your healthcare provider.
What types of seizures does EpiMonitor detect?
EpiMonitor is designed to detect patterns associated with generalized tonic-clonic seizures (GTCs) lasting at least 20 seconds. It does not detect absence, focal, or other non-convulsive seizure types.
Availability & purchasing
How can I buy EpiMonitor?
You can purchase EpiMonitor directly from the Empatica website. Simply visit the EpiMonitor store and follow a few simple steps to place your order. You will be able to choose your EmbracePlus color and subscription, as well as any additional accessories. Once a purchase is made, the EpiMonitor pack will be shipped to their address, including one EmbracePlus device, one charger, and instructions on how to download the companion EpiMonitor app.EpiMonitor also requires a prescription from a US-based healthcare practitioner to ship to US territories. You will be asked to upload this prescription to your account after you complete your purchase. You will not be asked to submit the prescription while purchasing.
How much does EpiMonitor cost?
EpiMonitor has a one-time device fee of $399 for the EmbracePlus, with monthly subscriptions starting at $15.90. Pricing may vary depending on your selected plan. For the most up-to-date information, please refer to this article.
Do you have a returns policy?
Yes, we offer a return policy for eligible purchases. If you're not satisfied, you can return the device within the first 30 days for a refund. Visit our Returns Policy page for more details.
Is EpiMonitor available in all US states?
Yes, EpiMonitor is available for purchase and use in all 50 US states.
Is EpiMonitor available outside the US?
Yes, EpiMonitor is available in select countries in Europe, and the United Kingdom. You can see the list of countries we ship to here.
Do I need a prescription before I buy?
US orders need a prescription to ship. You do not need a prescription to complete your purchase on the store, but you will need to submit a valid prescription while creating your account in order for us to ship your order. Orders without an uploaded prescription will be held and not shipped. Our team will reach out to you if they identify any issues with your order or prescription. If you live outside the US, no prescription is needed.
How can a doctor prescribe EpiMonitor and where do they send the prescription?
To prescribe EpiMonitor for patients in the US, doctors need to provide them with a paper or PDF prescription containing the required information. The patients will then upload an image of this to their account after purchasing EpiMonitor, so a member of the Empatica team can review its validity and release the shipment. If the prescription is not valid Empatica will contact the patient directly to explain why. If the patient is not able to provide a valid prescription to Empatica, their order will be cancelled and fully refunded. No prescription is needed for purchases made outside the US.
Can I use my insurance to pay for EpiMonitor?
Empatica does not bill insurance providers directly. However, some of our users have successfully managed to get EpiMonitor reimbursed after purchasing, by contacting their providers and using HCPCS code E1399. You can share our predetermination template with your doctor to discuss asking for reimbursement.
Are there ways to receive financial support in purchasing EpiMonitor?
We have partnered with a select number of charity organizations that help members of the epilepsy community get EpiMonitor for less. To see the list of charities you can reach out to, visit this article.
Connectivity & alerts
Does EpiMonitor need a smartphone?
Yes, EpiMonitor requires a compatible smartphone to operate. The phone runs the companion app and is responsible for alert notifications and data upload. The app needs to be installed on a phone used by the person wearing EmbracePlus. For a list of compatible smartphones, you can visit our compatibility page.
Will my child need a smartphone to use EpiMonitor?
Yes, all users, both adults and children, will need to have a dedicated smartphone to stay connected to EpiMonitor. This is because the EpiMonitor app, installed on the user’s phone, receives seizure information from the EmbracePlus via Bluetooth and triggers an alert when a possible seizure is detected.
Does the phone have to be next to the EmbracePlus watch to work?
EpiMonitor communicates with the smartphone via Bluetooth, so the phone needs to stay within range to transmit data and send alerts. EpiMonitor cannot work without a companion phone.
What is the EpiMonitor Bluetooth range?
The Bluetooth range is typically up to 15ft/5m in open spaces. Please be aware that walls and other obstacles may reduce the range, so make sure the phone is always close to EmbracePlus to reduce disconnections.
Does EpiMonitor call emergency services?
EpiMonitor does not directly call emergency services. Instead, it sends alerts to your designated caregivers, who can take appropriate action.
What is the range of an Alert?
As long as the smartphone is connected to the internet (Wi-Fi or cellular), alerts can be sent anywhere, across the room or across the globe.
Can EpiMonitor send false alerts?
Naturally, some movements or situations may trigger false alerts. Although the EpiMonitor false alarm rate is low (0.05 per day for adults and 0.02 per day for children during rest), we know these can cause unnecessary stress. That is why we have built two features into EpiMonitor to reduce false alarms further.
- False alarm cancellation: When the EpiMonitor algorithm detects a possible seizure, a countdown begins before an alert is sent, giving you the chance to cancel through the app or directly from the EmbracePlus watch with a few simple taps.
- Adjustable sensing precision: Our sensing precision feature allows you to adjust the sensitivity of the algorithm, or temporarily snooze it when you are in a safe situation, to ensure you balance peace of mind with whatever life plans you have.
Monitoring features & usage
Does EpiMonitor predict seizures?
Currently, EpiMonitor does not predict seizures. However, our seizure forecasting study (available to users in the US), is designed to collect real-world data to develop a forecasting algorithm. For more information visit our dedicated webpage.
How accurate is the EpiMonitor algorithm?
The EpiMonitor algorithm has a 98% accuracy and a False Alarm Rate (FAR) per day of 0.05 for children and 0.02 for adults during rest. In case of a false alarm, users have the option to cancel it directly from the watch or app.
What other metrics does EpiMonitor track?
EpiMonitor continuously monitors physiological signals such as movement and autonomic changes that may be associated with convulsive seizures. In addition, it monitors a range of sleep and activity data. For sleep, the metrics included are total sleep (including turns & tosses), effective sleep, sleep efficiency, and sleep fragmentation. For activity, the metrics included are total active time, steps, and activity intensity.
Does it monitor heart rate, SpO2 or breathing?
EpiMonitor does not monitor heart rate, SpO2 or breathing.
Can EpiMonitor be worn on the ankle, arm, or with a prosthetic?
For the sake of epilepsy monitoring and for the detection algorithm to work, EmbracePlus must be worn on the wrist and maintain skin contact. It cannot be worn on the ankle or arm, or with a prosthetic.
