EpiWatch Monitoring System

The EpiWatch Monitoring System is a software-only mobile medical application that works with a compatible wrist-worn device (such as an Apple Watch) to detect and alert users and caregivers about possible generalized tonic-clonic seizures. It continuously records physiological data from the wrist-worn device's built-in sensors and uses a proprietary algorithm to identify seizure patterns in adults and children ages 5 and up during periods of rest in home or healthcare settings.

Unlike the predicate Embrace device which uses proprietary EDA and accelerometer sensors in its own wrist-worn hardware, EpiWatch relies on third-party off-the-shelf wrist-worn devices (Apple Watch) with embedded physiological sensors. EpiWatch achieves a 10-fold reduction in false alarm rate compared to the predicate while maintaining equivalent sensitivity, without requiring users to manually set activity levels or restrict monitoring to rest periods only.

Not stated in this summary.

EpiWatch is substantially equivalent to the Embrace predicate because both devices have the same intended use (adjunct seizure monitoring), identical indications for use, and similar core functionality including wearer/caregiver monitoring, event detection and logging, alerting capabilities, and data recording/storage/transfer. Although EpiWatch uses third-party wrist-worn hardware instead of proprietary hardware, the company conducts compatibility assessments to ensure sensors meet specifications. Clinical testing on 242 subjects confirmed the device achieves 98% sensitivity for detecting true seizures with a false alarm rate of one per 12.4 days, demonstrating these technological differences do not raise new safety or effectiveness questions.