Search Results

The EpiWatch Monitoring System is a prescription, software-only mobile medical application intended for use with a compatible wrist-worn device as an adjunct to seizure monitoring of adults and children ages 5 and up in home or healthcare settings during periods of rest. The EpiWatch Monitoring System continuously records, stores, displays, and transfers data from the compatible wristworn device's built-in physiological-based sensors to support review by healthcare professionals, and people with epilepsy (PWE) or at risk of epilepsy. When the EpiWatch Monitoring System detects and logs physiological patterns associated with generalized tonic-clonic seizures (TCS), the EpiWatch Monitoring System application alerts the identified caregiver(s) to notify of detected possible seizure events.

The EpiWatch Monitoring System is a non-electroencephalogram (non-EEG) physiological signalbased seizure monitoring system. It is similar to other legally-marketated non-electroencephalogram (non-EEG) physiological signal-based seizure monitoring systems. The EpiWatch Monitoring System consists of a software-only mobile medical application intended for use with a compatible wrist-worn device as an adjunct to seizure monitoring of adults and children ages 5 and up. EpiWatch Monitoring System is a software platform composed of: - A compatible wrist-worn device, (e.g. an Apple Watch) - A mobile application running on smartphones called the "EpiWatch Monitoring System . App". The wrist-worn device continuously collects raw data via specific sensors, and feeds consolidated physiological data to the EpiWatch app via APIs. Utilizing a proprietary algorithm, EpiWatch analyzes and assesses the physiological data and determines if there is suspected generalized tonicclonic seizure activity (TCS). The EpiWatch algorithm has been validated through testing, using the gold-standard video electroencephalogram (vEEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, of epilepsy patients experiencing TCSs in hospital Epilepsy Monitoring Units. When a likely TCS is detected, the EpiWatch Monitoring System App communicates to the EpiWatch Cloud which initiates, through an external provider, a voice call, email and an SMS text message (notification parameters are set by the user at contact setup) to summon the attention of caregiver(s). In addition to initiating alerts, the EpiWatch app also continuously receives all the sensor data collected by the wrist worn device. The EpiWatch App is also responsible for transmitting-over a cellular data plan or Wi-Fi connection-the API data, device information, and computed physiological parameters to the EpiWatch Cloud for further review and storage, which allows seizure reports and other features added to alerting. It also provides necessary information about the state of the system.