Embrace: The First FDA-Approved Smartwatch in Neurology Can Predict Epileptic Seizures

Embrace is a biosensor device whose sensors convert biological signs from the body into signals and medical data, store them, pair wirelessly with smartphones via Bluetooth, and transfer health data to the paired device. Unlike other smartwatches, Embrace continuously processes sensor data and runs an embedded algorithm to predict whether a person will experience an epileptic seizure, specifically a generalized tonic-clonic seizure. Because it can successfully issue seizure alerts, it received approval as a “medical device” in January 2018 from the FDA .

An algorithm is a procedure created to solve a problem, which can be thought of as “Problem + Algorithm = Solution.” Algorithms are not exclusive to medicine but are used extensively in medicine and engineering. Healthcare artificial intelligence systemsare designed to know thousands—or even unlimited numbers—of algorithms.

Embracemeans to hug or holdin Turkish translation.

The Epilepsy Algorithm Inside the Smartwatch

The algorithm was validated using data labeled through electroencephalography (EEG), the standard diagnostic methodology for epilepsy, designed by epileptologists at an advanced epilepsy center. When it detects a possible seizure, the Embrace algorithm sends a message to another smartphone application to alert designated caregivers. This substantially reduces the caregiver’s response time.

How Embrace Was Developed

Seizure-monitoring research leading to the Embrace smartwatch began in 2007 at the MIT Media Lab with Dr. Rosalind Picard, Empatica’s chief scientist and director of the Affective Computing Group. Picard initially developed icalm , a device measuring stress levels. Her assistant then suggested that it could use certain body signals to detect epileptic seizures.

In 2014, the Empatica team launched studies at Boston Children’s Hospital in level 4 epilepsy centers. These studies used artificial intelligence to recognize complex physiological patterns in electrodermal activity that may lead to epileptic seizures, helping develop the seizure detection algorithm. As more data were collected, machine learning improved the seizure classification algorithm. Empatica applied to the FDA with a 1500-page report explaining the watch, its epilepsy algorithm, and clinical findings, securing medical-device approval in January 2018. Embrace thus became the first FDA-approved smartwatch in neurology.

Previously, in 2012, AliveCor’s KardiaBandand, in 2017, Apple Watchhad received FDA approval for detecting heart rhythm disorders, particularly atrial fibrillation. KardiaBand integrates into Apple Watch as a watchband. Also in 2017, AliveCor announced SmartRhythm, using artificial intelligence together with Apple Watch’s built-in heart-rate and activity sensors to monitor the relationship between physical activity and heart behavior. If these are out of sync, it recommends that the user record an ECG with KardiaBand.

Wearable technologies have already become part of our lives. Many applications and technologies aim to improve quality of life and support a healthy body. Similar applications could soon become lifelines for patients on the other side of the world.

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