Embrace
Empatica SrlEmbrace is a wearable device worn on the wrist that monitors physiological signals such as Electrodermal Activity, motion, and temperature to detect generalized tonic clonic seizures in patients with epilepsy. It helps alert caregivers by sending notifications during seizure events, assisting in timely monitoring and care for patients both at home and in healthcare facilities.
Intended Use
The Embrace is a prescription only device indicated as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. It senses Electrodermal Activity and motion data to detect patterns associated with generalized tonic clonic seizures and sends alerts to designated caregivers.
Technology
The device is a wearable biosensor worn on the wrist that captures and transmits sensor data including Electrodermal Activity, accelerometer, and temperature via Bluetooth. An onboard algorithm continuously processes these data to detect generalized tonic clonic seizures and sends alerts to paired caregiver devices.
Performance
Clinical testing involved 141 epilepsy patients monitored in epilepsy monitoring units, recording 54 generalized tonic clonic seizures. The device demonstrated a high positive percent agreement (PPA) of 0.9815 for detecting seizures and a false alarm rate (FAR) of 0.94 per 24 hours. These results support the device’s ability to detect seizures effectively.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/12/2018
5 months - 2
FDA Approval
12/20/2018
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