The Food and Drug Administration (FDA) has granted marketing clearance to the Embrace Smartwatch for use in children 6 years or older. Embrace is an epilepsy smartwatch which is used to track and manage seizures.
Embrace is designed and developed by Empatica, Inc. Empatica is a Cambridge, USA based company which works in manufacturing devices for medical research and epilepsy management.
The Embrace smartwatch has been previously approved by the FDA for adults in January 2018.
Embrace is the world’s first smartwatch for use in epilepsy management. It detects patterns and physiological signals that are related to generalized tonic-clonic seizures and alerts the caregivers of the patients. Embrace also analysis sleep, rest and physical activities.
A generalized tonic-clonic seizure is a type of seizure which causes loss of consciousness and muscle contractions. It occurs due to overactivity in the brain.
According to a recent study by the Centers for Disease Control and Prevention (CDC), 3.4 million (34 lakh) people suffer from epilepsy in the US. Out of these 470,000 are children. There are 10 million people who suffer from Epilepsy in India and 50 million people worldwide.
During clinical trials, the Embrace smartwatch was tested on 141 patients suffering from epilepsy. In the study, 80 pediatric patients were between 6 to 21 years of age. Seizures in 53 out of 54 patients were detected by Embrace, resulting in 98% of detection in seizures.
“We are so happy to provide Embrace with FDA's formal clearance of its use by pediatric subjects aged 6-21. Embrace improves the likelihood that a trusted caregiver will be there during the critical moments after a seizure happens. Having somebody present is associated with better health outcomes" the Chief Scientist at Empatica, Rosalind Picard said.
Orrin Devinsky, one of the leading experts in Epilepsy and Director of the Comprehensive Epilepsy Center at NYU said, "The clearance of the Embrace watch to detect seizures in children ages six years and older is an important step forward in our ability to identify seizures rapidly and thereby allow parents or others to respond."
Previously, clinical trials had to rely on patients to self report their seizures in a diary. This process was considered to be inaccurate and less reliable. More than 40% of the most dangerous seizure are not reported, but as the company claims with the help of Embrace, reporting of seizure have become more efficient and easy.
The company claims that the Embrace smartwatch will help patients and their families get medical attention sooner. It will also help patients and caregivers to take control of situations much faster.