Embrace, the first smart band for epileptic seizures gets FDA approval

Embrace, the first smart band for epileptic seizures gets FDA approval

Wearable tech is becoming increasingly popular around the world. Smart little sensors providing the everyday man with health data and information is now a growing market, and it’s extending into the medical arena in a big way too.

Many organisations and research teams are finding ways to develop wearables for a variety of different functions. In the medical space, a fair majority of these devices are aimed at providing detectable care in addition to more traditional treatments. In this way, wearable tech is helping patients to improve their quality of life and better manage their medical conditions.

There are plenty of devices being researched and developed, with many making significant progress in testing environments. The new kid on the block for health tracking is a wearable product called Embrace which is geared towards better managing the most debilitating symptom of epilepsy – seizures.

Empatica Inc., a spin-off of MIT Media Lab (an interdisciplinary research laboratory at the Massachusetts Institute of Technology, USA), and the developer of Embrace is an organisation that designs and manufactures in-house. The organisation has offices in Cambridge, Massachusetts (USA), and Milan, Italy. Research devices which they have developed are already being used by institutional partners in their thousands, including research organisations, top hospitals and pharmaceutical companies. Hardware, software and data science is their core interest, with the company having been involved in numerous studies researching sleep and sleep disorders, migraines, stress, depression, and now epileptic seizures.

On 5 February 2018, Empatica Inc. excitedly announced that their seizure-monitoring smart band, Embrace, had received FDA (U.S Food and Drug Administration) clearance for marketing. The official thumbs-up from the FDA was received on 26 January 2018. The FDA effectively issued a 510(k) clearance (section 510(k) of the Food, Drug and Cosmetic Act, also referred to as a pre-market notification), which allows Empatica Inc. to register their new device with the intent to market within 90 days.

The greenlight given by the FDA now means that Embrace is the first-of-its-kind wearable seizure-monitoring device intended to be used by patients managing epileptic conditions, helping them to detect convulsive seizures. Added benefits to the Embrace system is that the device alerts caregivers selected by the patient, who can assist in providing additional clinical care when the person in question needs it most. The smart band also captures general well-being data, including physiological stress patterns, physical activity, sleep and rest. FDA clearance comes almost a year following regulatory approval in Europe, which was given in April 2017.

Embrace is an exciting development in the field of neurological medicine. Epilepsy is regarded as one of the world’s most common neurological medical conditions. The World Health Organisation (WHO) estimates that over 50 million individuals worldwide have diagnosed epileptic conditions – many of whom are children. Those with active conditions (i.e. individuals who experience frequent seizures) is estimated to be between 4 and 10 per 1 000 individuals. (1) 

A high percentage of individuals undergoing treatment for epilepsy don’t respond effectively enough to pharmacological interventions, and others appear to respond only partially well. For those living with the condition, having a seizure can be a frightening experience. The fear of what can go wrong when a person is not in control of their physical being is very real. Complications ranging from injuries sustained during a seizure to psychological problems (like anxiety) and medication side-effects are constant concerns. Seizures lasting up to 5 minutes can also result in severe brain injury, another complication many are fearful of. Sudden unexplained death (SUDEP) is an extreme complication which can occur during or following a seizure and may involve severe breathing and heart rhythm difficulties. Although an extreme complication, SUDEP is known to affect thousands of epilepsy sufferers every year.

A management tool which provides epilepsy sufferers with additional treatment support is something many will surely welcome. Embrace has seemingly earned its stripes and proven that it can be used as a viable medical device which offers additionally effective assistance during critical moments.

How Embrace came to be

The technology behind this smart band has been around for some time, and through the years has been consistently tested and refined. Chief scientist at Empatica Inc., Dr Rosalind Picard (who is also Director of the Affective Computing Group at MIT Media Lab) has been involved with seizure monitoring research since 2007.

“It’s been quite the journey,” she says.

Picard has been heavily involved in researching wearable stress and emotion sensors through numerous studies (using Empatica’s scientific version – the E4). During 2014 a series of studies were conducted at numerous level IV certified epilepsy centres. It was through these studies that a seizure detection algorithm was noted using Artificial Intelligence (AI) methods that could decipher intricate physiological patterns associated with a convulsive seizure.

When Picard and her team accidently discovered that distinctive skin changes brought about by activity in the brain associated with various seizure types could be picked up, the idea of developing a multimodal wearable device seemed considerably more achievable. Since then, the algorithm has been refined and improved for classifying seizures in order to achieve clinical results. It’s been shown in subsequent research studies that multimodal wrist-worn detectors (like Embrace) can accurately provide seizure counts, more so than previous automated detectors and patient self-reports of convulsive seizure experiences. Multimodal systems can also potentially function as a warning system for possible SUDEP occurrences. (2)

Picard herself, seems very excited to see laboratory work now materialise into an easy-to-use and fully functional consumer-facing product in the medical industry.

A medical-quality device made consumer-friendly

In 2015 Empatica Inc. launched Embrace through a crowdfunding campaign. With the technology already showing positive results in studies, the campaign was angled around refining a high-quality design. The company knew then that the product needed to factor in its market. If the devices were going to sell and be used, they also need to be attractive and practical for everyday wear. With many medical devices designed for specific functions being uncomfortable or bulky, Empatica Inc. felt the need to refine the design well before it was officially recognised for medical use, so that those it was intended for would actually be keen to wear it once it was released to market.

The organisation not only wanted to produce an effective medical device, they also had eyes on becoming the manufacturer of an award winning smart band in the field of design. And they have already achieved this, winning multiple awards during 2015 and 2016.

The company wants to market a product that’s both medically useful and sleek to look at. Co-founder and CEO of Empatica Inc. Matteo Lai believes that this consideration is one of their key success points to date, paving the way for other healthcare device developers to do the same.

“Cutting edge technology and good design need to go together,” he says.

Many previous research studies looking at epileptic seizures have relied on information obtained directly from patient participants – self-reporting seizure episodes in diary format. This can so easily result in slightly skewed or inaccurate information being accumulated, with a high percentage of the most dangerous seizures not being recorded.

Empatico Inc. already knew that their technology could potentially test well when it came to real-time data and accuracy. For them, Embrace is the answer to reducing inaccurate information. Their device could provide a favourable alternative to study patients only wearing EEG (electroencephalography) monitoring electrodes. With technology that is highly sensitive, data is easily automated, making the smart band user-friendly outside of a hospital or medical facility environment. Coupled with practical (and sleek) design, the device isn’t cumbersome and uncomfortable to wear either. It can easily fit into everyday life.

Research gets a stamp of approval

To achieve a stamp of approval in the medical space, Embrace had to be proven as a viable medical device. According to a press statement provided by Empatica Inc. on 5 February 2018, clinical studies involving 135 epileptic patients were conducted. Researchers admitted the participating patients to epilepsy monitoring units where continuous monitoring took place over more than 272 accumulated days. Data was collected via video electroencephalography (now a ‘gold-standard’ for epileptic seizure diagnosis) and electrodermal activity (EDA – also referred to as skin conductance) obtained from the wearing of the Embrace device at the same time.

Video electroencephalography, also referred to as EEG-video monitoring allows analysts continuous recorded data over a prolonged period. Recorded behaviours via video and measured EEG activity allows for accurate diagnosis of seizures experienced by a patient and can help to identify the nature of potential non-epileptic attacks (where relevant). Such monitoring tools are especially useful for healthcare providers and their patients who have regular seizures even though they are undergoing treatment with anti-epileptic medications.

Electrodermal activity involves the variation of electrical properties and autonomic skin changes as a response to the secretion of sweat. Physiological changes can then be quantified as they relate to a person’s ‘fight or flight’ response (i.e. sympathetic nervous system activity). Thus, EDA technology in Embrace can then be useful for helping to measure multiple indicators of a possible seizure.

According to the statement, the research collected over 6 530 hours’ worth of data and recorded 40 generalised tonic-clonic seizures (convulsive seizures formerly referred to as ‘grand mal’) experienced by participants. These seizures involve a loss of consciousness by a person who also experiences violent muscle contractions, which can last up to two minutes. Independent epilepsy experts (epileptologists) helped to confirm that the algorithm of the Embrace device detected 100% of the recorded seizures without even looking at the device data directly. Experts made their confirmations of the seizures by reviewing the recorded video-EEG data only.

The Empatico Inc. research team filed their findings as part of a 1 500-page application to the FDA in 2016, which they felt substantiated their goals well enough. The application provided technical and scientific details supporting the Embrace system for neurological use.

How does the Embrace system work?

Embrace makes use of advanced machine learning (AI) / patented technology which effectively identifies the occurrence of convulsive seizures in epileptic patients. The device records physiological signals from a user via multiple sensors. This then triggers an alert system making use of text and phone messages, flagging an emergency to selected caregivers. Transmitted data thus pairs with a Bluetooth connection (a wireless area network technology that has a low consumption of power) from a compatible mobile device (phone) via secure servers (through the use of an internet connection). A user wearing the device must be within a 30 foot / 10 metre range of their mobile phone device for the connection to work.

The device comprises of an EDA sensor which measures sympathetic nervous system activity (or sympathetic arousal). When a person experiences arousal or excitement, physical, cognitive and emotional stressors are triggered. In the case of an epileptic patient, such triggers indicate significant increases related to the activation of specific brain structures (the amygdala / hippocampus). Once these brain structures are activated or stimulated, triggers in the skin occur.

The skin is a crucial factor here as it is the only organ that is entirely activated by the sympathetic nervous system while remaining unaffected by parasympathetic activation (i.e. a process stimulated by relaxation). This means that skin related measurements can serve as a reliable parameter for the detection of convulsive epileptic seizures. The EDA sensor (with multiple exposed EDA electrodes on the bottom cover of the device) is highly sensitive and when worn can pick up and monitor subtle electrical changes on the surface of the skin, as well as changes (including high frequency levels) in a person’s heart rate. Heart rate measurements that spike can help to flag potentially severe seizure complications, especially those associated with SUDEP. Measurements can thus be made in a non-invasive manner and assistance rendered by alerted caregivers when necessary.

Empatica Inc. Embrace wearable device for the detection of epileptic seizures.

The device also comprises of a gyroscope which measures rotational speed (useful for when a user’s limb’s experience rotation during a fall), a peripheral temperature sensor that tracks skin temperature (which is important as a seizure is often accompanied by a fever) and a 3-axis accelerometer for measuring high sensitivity motion across 3 axes (X, Y and Z). The accelerometer helps to measure g-force (acceleration) that is relative to a free-fall. The motion component combined with EDA provides better automated detection for generalised tonic-clonic seizures.

The electronics board also includes a central processing unit (CPU), Bluetooth antenna, LEDs, touch sensor and a lithium polymer battery (making the device lightweight and capable of giving the user the convenience of long battery life).

The device has a waterproof case (made out of anodised aluminium), adding to its user-friendly appeal and also improving durability, as well as an analog watch and comes with interchangeable bands – a popular marketing feature for all wearable devices on the market. Embrace is easily adjustable for any size wrist, including that of a child, and comes in a small range of appealing colours – black, grey, blue and pink.

Range of colours available for the Embrace wearable device.

When the smart band detects a seizure, it vibrates, alerting the user who may or may not be able to respond. Like most wearable tech, the Embrace smart band links up with a digitised mobile application. If a user does not respond to the vibration on the smart band, this is where the app comes into play as an alert system for a designated caregiver.

A user of the system is required to have a smartphone device in order to use Embrace. The app works hand-in-hand with the smart band and is available for download on App Store and Google Play. The app (connected to the smart band via Bluetooth) is geared to be programmed by a user so that automated alerts can be sent to their chosen caregivers. A phone call or SMS immediately activates the moment the system detects a convulsive seizure via the smart band.

Alerts require cellular data or a Wi-Fi connection in order to dispatch the notification. A caregiver, however, does not necessarily need a smartphone in order to receive an alert from the system. A cellular signal is adequate enough to receive the all-important SMS or phone call. The caregiver in question can then take appropriate action when it comes to ensuring that the affected person receives the medical care they need, and swiftly.

Embrace app system.

The Embrace system comes with a tiered subscription plan (lite, standard and plus) and in order to make the most of it, a user can tailor their use according to their needs. Predictably, the standard and plus plans have more features and benefits but are not seemingly overly priced for the average consumer.

The lite package is available for $9.90 per month. The standard plan offering is priced at $19.90 per month and the plus package at $44.90 per month.

The higher tiered plans offer enhanced alert function by providing precise GPS locations when issuing notifications to caregivers. A rest mode (which can be manually set) and gives the user more personalised functionality of the system is also available to standard and plus plan users. An unlimited number of caregivers can be loaded on the plus plan. The standard and plus plans allow for easy management of caregiver listings – a user can enable or disable users on the app at any time, so as to ensure that there is always someone available to assist should the need arise.

Embrace is already available for purchase at around $249 (excluding shipping) but is now recognised for neurological use and will soon be marketed directly to epileptic patients.

For those in the medical field Embrace and its marketing approval achieves a major milestone in the detection of convulsive seizures in real-time – as a seizure is happening.

For an epileptic patient, prompt attention and assistance can potentially be the lifesaving factor that reduces extreme complications and adds valuable quality of life. If it’s possible to achieve, the next steps in such technological advancements may just be predicting an epileptic seizure before it actually occurs, and that is something those with the condition and medical professionals alike would surely like to see.


1. World Health Organisation. February 2018. Epilepsy Fact Sheet: http://www.who.int/mediacentre/factsheets/fs999/en/  [Accessed 16.02.2018]

2. US National Library of Medicine National Institutes of Health. November 2017.Multicenter clinical assessment of improved wearable multimodal convulsive seizure detectorshttps://www.ncbi.nlm.nih.gov/pubmed/28980315 [Accessed 16.02.2018]