US Food and Drug Administration
Empatica Inc. has announced that its artificial intelligence (AI) smartwatch, Embrace, has received approval from the US Food and Drug Administration (FDA) for the monitoring of grand mal, or generalized tonic-clonic, seizures.

The MIT Media Lab spin-off company’s watch uses its machine-learning capabilities to allow it to send alerts to caregivers of patients with epilepsy, allowing them to reach patients more quickly. It connects via Bluetooth to compatible smartphones and must be within the range, roughly 30 feet, from the phone.

Previously, in April 2017, the watch was approved by the European Medicines Agency (EMA) for seizure monitoring and alert.

The Centers for Disease Control and Prevention (CDC) estimates that of the 3 million patients with epilepsy in the United States, roughly 500,000 are children, and in total, 35% of patients do not respond to antiepileptic medications.1 Additionally, generalized tonic-clonic seizures, which result in a loss of consciousness, have been estimated to occur without being reported at a rate of 40%, according to clinical estimates.2

"The FDA approval of the Embrace device to detect major convulsive seizures represents a major milestone in the care of epilepsy patients,” Orrin Devinsky, MD, director of the Comprehensive Epilepsy Center at New York University, said in a statement.3 “Tragically, more than 3000 Americans die each year from Sudden Unexpected Death in Epilepsy (SUDEP) and the Embrace offers the potential to alarm family members and caretakers that a tonic-clonic seizure is occurring. The scientific evidence strongly supports that prompt attention during or shortly after these convulsive seizures can be life-saving in many cases."

Approval for the watch was granted based on data from a multicenter clinical trial including 135 patients with epilepsy that were admitted for continuous monitoring via video electroencephalography (EEG) over the course of 272 days. Each patient was given a watch to wear during the monitoring period.

Over the 6500 hours of recorded data, 40 generalized tonic-clonic seizures were observed. To determine efficacy, all seizures were required to be clinically affirmed by ≥2 of 3 independent epileptologists, all 3 of which made assertations without the use of the Embrace data. The results revealed that the smartwatch detected all 40 with 100% accuracy.

“It's been quite the journey—we have worked for years building wearable stress and emotion sensors, and then accidentally discovered we could pick up changes in the skin elicited by brain activity related to the most dangerous kinds of seizures,” Rosalind Picard, SM, ScD, director of the Affective Computing Group and chief scientist at Empatica, said in a statement. “It has been very meaningful to see this technology move from the lab into the most accurate, beautiful and easy to use sensor on the market.”

The approval marks a milestone in the field of neurology, as an alternative to wearing an EEG has long been sought after to decrease burden for patients. The watch, which is not bulky or cumbersome, utilizes electrodermal activity signals to determine sympathetic nervous system activity—detected via its use of Electrodermal Activity (EDA). This activity sensor serves as somewhat like an alternative biomarker, and as a definite alternative to wearing an EEG, allowing for easier monitoring of these patients.

"Medical devices face a huge problem: they're usually too bulky and uncomfortable, and people simply don't want to wear them. Empatica took a different path,” Matteo Lai, BSc, MSc, the CEO and co-founder of Empatica, said in a statement. “We wanted to design the world's first medical device that could win a design award while being used as a lifesaving product. Patients actually love Embrace and are proud to wear it. We think this has been one of the keys to its success and an interesting lesson for healthcare. Cutting-edge technology and good design need to go together.”
REFERENCES
1. Epilepsy data and statistics. CDC website. cdc.gov/epilepsy/data/index.html. Updated January 17, 2018. Accessed February 6, 2018.
2. Burneo JG. The real truth behind 
seizure count. Epilepsy Curr. 2008;8(4):92-93. doi: 10.1111/j.1535-7511.2008.00251.x.
3. Embrace by Empatica is the world’s first 
smartwatch to be cleared by the FDA for use in Neurology [press release]. Cambridge, Massachusetts. Empatica Press Office; February 5, 2018. prnewswire.com/news-releases/embrace-by-empatica-is-the-worlds-first-smart-watch-to-be-cleared-by-fda-for-use-in-neurology-300593398.html. Accessed February 6, 2018.