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Intended Use Statement

The nEureka® System is designed for self-reporting of ongoing or past epileptic seizures and other general auto-captured parameters such as heart rate. The seizure data is collected by a mobile app on a smartwatch, and this information is displayed on the nEureka® Remote Care Hub, along with optional sleep monitor data. The system can also provide alerts to non-medical caregivers and track medication adherence and side effects.

The data collected with the nEureka® System can also be transmitted through the cloud to the nEureka® Clinic Portal for review by a healthcare provider. The system does not provide any active monitoring, real-time alerts, or treatment recommendations to the clinician and is meant to serve as a secondary display to the nEureka® Remote Care Hub