Recently, the American startup Empatica announced that it has approved its world's first smart watch "Embrace" in the field of neurology, which uses AI technology to monitor seizures and issue alarms to summon caregivers. Prior to this, Embrace was approved in Europe as a medical device for epilepsy monitoring and alerting.
It is understood that unlike other traditional monitoring equipment, Empatica can measure multiple indicators of seizures. The biggest highlight is the use of “skin electrical activityâ€, which is used by stress researchers to quantify sympathetic nervous system activity. A signal of physiological changes that allows a patient's seizure to be detected as soon as possible.
The timeliness and effectiveness of Embrace monitoring have also been confirmed in previous clinical trials. In a multi-site clinical study, 135 patients with epilepsy underwent continuous monitoring of the video EEG of the fourth-level epilepsy monitoring unit while wearing the Empatca device, which recorded 6530 hours of monitoring data over 272 days. The results show that Embrace's algorithm can detect 100% of seizures. In this trial, the gold standard used to confirm seizures was video EEG data observed by at least two-thirds of independent epilepsy experts, during which they did not see any Embrace data.
According to the latest data from the US Centers for Disease Control, 1.2% of the US population has epilepsy, about 3.4 million patients, including 470,000 children, and about 35% of seizures do not respond to drug control, while another three points One of the patients only partially responded to the drug.
Among them, the onset of systemic tonic-clonic seizures leads to loss of consciousness and may cause confusion in the following period of time. Traditionally, clinical trials must rely on self-reporting in the diary when the patient is onset. However, this method has a low accuracy and is not effective in preventing seizures. However, Embrace's high sensitivity makes reporting of seizures easier and more accurate. And will immediately alert the caregiver so that the patient can get help in time.
For the approval of Embrace, Orrin Devinsky, director of the New York University Center for Epilepsy and one of the world's top epilepsy experts, said: "The FDA has approved Embrace for the monitoring of amnesia, an important milestone in the care of patients with epilepsy. More than 3,000 Americans have died of sudden and unexpected deaths from epilepsy. Embrace equipment can provide family members and caregivers with an alarm of tonic epilepsy, and the attention of caregivers can be quickly gained during or after these episodes. Saving lives in the situation has been supported by scientific evidence."
Dr. Rosalind Picard, chief scientist at Empatica, said: “We have been working on manufacturing wearable stress and emotional sensors for many years and then surprisingly found that we can get skin from changes in brain activity related to the most dangerous seizures. Change signals, now the most accurate, convenient and fastest sensor technology from the laboratory to the market, is very meaningful."
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