Seizure Detecting Embrace has Received Clearance from the FDA

Seizure Detecting Embrace has Received Clearance from the FDA

The Embrace watch from Empatica has been granted clearance by the Food and Drug Administration in the United States and is now considered an approved medical device. Midway through 2016, the company began working on the file, and the final package ended up being almost 1,500 pages long! Since April of 2017, Embrace has been recognised as a legitimate medical device in the European Union.

The FDA has given its approval to the seizure and stress monitoring wearable Embrace.

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The wearable device resembles a cross between a wristwatch and a fitness band in terms of its design. However, hidden within this one-of-a-kind device are a collection of sensors that set it apart from the rest of the pack. This comprises a three-axis accelerometer, a gyroscope, a temperature monitor, and an electrodermal activity sensor (sweat induced moisture sensor).

Activity, sleep, and stress levels may all be monitored using Embrace. More crucially, the tracker’s artificial intelligence (AI) and one-of-a-kind mix of sensors enables it to identify spikes in any activity, indicating whether a user is nervous, sad, stressed, or about to have an epileptic seizure.

An alarm will sound if something out of the ordinary takes place, such as a convulsive seizure, when epileptic patients are wearing their Embrace monitors. It will be sent to their parents, roommates, or carers via their smartphone, so that somebody will be able to check on them.

Epilepsy affects 3.4 million people in the United States at some point in their lives, which is a statistic that is not widely understood. More than 65 million people are affected all around the world. Embrace is able to identify the most severe forms of seizures, which are referred to as “grand mal” or “generalized tonic-clonic” seizures.

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Anyone can use the wristband to monitor their stress levels, which is essential for maintaining a healthy lifestyle and can be used in addition to detecting seizures. When you are in a state of excitement or stress, whether it be physical, emotional, or cognitive, your sympathetic nervous system becomes more activated. Stressors, whether they be mental, emotional, or physical, can also contribute to an increase in this. The wearable device detects increases in sympathetic activity by tracking minute electrical changes that occur across the skin’s surface.

In addition to this, you can use Embrace to monitor your overall activity and to keep tabs on the ratio of sleep to wakefulness during the day. However, it does not supply any information on the stages of sleep that a person is in or their heart rate.

Orrin Devinsky, one of the world’s best experts in epilepsy and the Director of the Comprehensive Epileptic Center at NYU, stated that the clearance of the Embrace device by the FDA to detect large convulsive seizures signals a major milestone in the treatment of epilepsy patients.

“Unfortunately, over 3,000 people in the United States pass away every year from a condition known as Sudden Unexpected Death in Epilepsy (SUDEP), and the Embrace has the ability to alert family members and carers that a tonic-clonic seizure is occurring. In many instances, receiving rapid medical assistance during or shortly after a seizure that causes convulsions can be life-saving. This is a hypothesis that is highly supported by the scientific evidence.

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