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Discover our new service for healthcare providers: Remote Seizure Monitoring

Our goal, here at Empatica, has always been to provide intelligent technology to help people with epilepsy live better. Part of this dedication also involves giving physicians the tools that they need to provide better care for their epilepsy patients. With this in mind, we were very excited to announce our new service for healthcare providers called Remote Seizure Monitoring, at AES 2019 in Baltimore a few weeks ago.

Our new solution converts the data from our FDA-cleared, seizure detection algorithm of Embrace2 into a monthly report. The report is complete with detailed seizure, rest, and physical activity information to help doctors offer customized, data-driven care without having to rely only on patient self-reporting and seizure diaries, and better yet, it is reimbursable by Medicare.

How does it work?

With Remote Seizure Monitoring, patients will be supplied with our beautiful smart watch, Embrace2, that detects possible generalized tonic-clonic seizures (GTCS). It has a 98% accuracy in detecting GTCS and a 0.94 False Alarm Rate (FAR) per day. [1] During rest, the overall FAR was 0.05 for children and 0.02 for adults [2], so physicians can rely on our detection algorithm. This is especially true for moments when a patient may not remember having a seizure, like during the night.

Since it can be worn comfortably on the wrist, it can be worn both day and night, so Embrace2 can continuously collect seizure data while patients go about their days. As a result, physicians will have access to physiological data for each automatically detected GTCS: accelerometry information, electrodermal activity (EDA), and peripheral temperature.

This information could be useful to help physicians determine if a patient is experiencing GTCS and make more informed treatment decisions. Also, they can view this alongside a patient’s rest and physical activity to determine if there are any patterns.

So, how will all of this information look inside of the report? Let’s move on to the next section.

What’s inside the report?

Our report is designed to give physicians a monthly overview of seizure, rest, and physical activity all on one page. At a glance, a physician can review the aggregate stats to see the hourly seizure frequency and any variations in rest and physical activity. Thanks to the color-coding, it is also possible to easily identify if a patient is having seizures during rest (most likely at night) or during the day.

Doctors will have access to objective, accurate seizure data for automatically detected GTCS. The seizures that are automatically detected by the FDA-cleared algorithm in Embrace will appear in the report, after the patient confirms them, so physicians will have reliable seizure counts. As research has shown, patients underreport more than half of their tonic-clonic seizures and up to 86% of nocturnal seizures go unreported, understandably so since patients are either sleeping or alone at night when they happen. [3]

Alongside the objective data, physicians can see patient-reported seizures; this can also include other seizure types that a patient may experience that Embrace does not detect. On the following pages, the objective physiological data for each detected seizure is shown. With all the combined information, doctors will be able to make better informed treatment decisions.

How does it work for patients?

If a doctor enrolls their patients in our Remote Seizure Monitoring service, we will send them our FDA-cleared Embrace2 wristband. They will be able to easily set up the device at home, with no need for an additional office visit or intervention from the physician. Our Customer Happiness team will take over at that point and assist patients in setting up the device and learning the ropes.

Patients who are using Embrace2, with Remote Seizure Monitoring, will also be using our Mate App, which doubles as a handy seizure diary for their benefit. To assist patients in maintaining a thorough diary, the possible GTCS that Embrace detects are automatically visualized in Mate, providing patients with a reliable basis to add notes on the duration and what they were doing before the seizure happened. We added these additional features in Mate to help patients provide useful information to assist their physicians to identify potential seizure triggers.

In addition to their seizure activity, Mate also shows patients their rest and physical activity to help them identify patterns about their lifestyles.* It’s a little bonus to help patients stay engaged while wearing Embrace2.

What are some other benefits for both physicians and patients from Remote Seizure Monitoring?

Well, one of the primary benefits is in the name itself: remote. All of the seizure monitoring is done remotely in the comfort of the patient’s home, and they can go about their daily lives uninhibited by the device. They can also take showers with Embrace, as it is waterproof.

In addition, there is no need for inpatient visits to set up the device, freeing up time for everyone involved. The report is conveniently sent to doctors once a month by the Empatica specialists. If desired, they could even do a remote medical visit or have a follow-up phone call with their patients with the report in their hands.

Lastly, it is reimbursable by Medicare through three Remote Patient Monitoring codes: 99453, 99454, and 99457, facilitating its use by physicians.

In conclusion, our new service can be helpful as an additional monitoring tool, and we hope that it empowers physicians to make more informed treatment decisions for their epilepsy patients. If you are interested in this service, talk to our team.

If instead you are a patient and are interested in your physician using this service, you can ask them about it at your next appointment or send them to our website for more information.

*We do not guarantee that Embrace and the Alert App will detect every single seizure. The rest and movement information displayed is not intended to make any diagnostic recommendations, but instead, it can give insights on the patient’s overall rest and physical activity.

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Sources:

1. FDA 510(K) (K181861) Summary Empatica Embrace physiological signal based seizure monitoring system, 2018.

2. Onorati F, Regalia G, Carboni C, et al. Prospective evaluation of generalized tonic-clonic seizure multimodal detection: comparison between pediatric and adult cohorts in EMU [abstract]. In: American Epilepsy Society Meeting; 2019 Dec 6-19; Baltimore, ML. Abstract nr 1.095.

3. Hoppe C, Poepel A, Elger CE. Epilepsy: Accuracy of Patient Seizure Counts. Arch Neurol. 2007;64(11):1595–1599. doi: https://doi.org/10.1001/archneur.64.11.1595

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Embrace is currently available only in English. Embrace is an investigational device in the USA and a medical device in the EU. If you do not see your country listed, please visit the International site.
Please note that Embrace Alert System is not available in the following countries .