EpiWatch reports Phase III seizure detection study in Neurology Open Access

By AI, Created 5:27 AM UTC, May 28, 2026, /AGP/ – EpiWatch said its Apple Watch-based seizure detection app showed 98% sensitivity and a low false alarm rate in a Phase III study published in Neurology Open Access. The results, drawn from 242 participants ages 5 and up across six epilepsy monitoring units, could support broader use of wearable alerts for tonic-clonic seizures.

Why it matters: - Tonic-clonic seizures can cause injury and raise the risk of Sudden Unexpected Death in Epilepsy, especially for people who sleep alone. - Wearable seizure detection can help caregivers respond faster and may improve safety for people with epilepsy. - The publication adds clinical evidence for consumer wearable-based seizure alerting, which remains a key barrier to wider adoption.

What happened: - EpiWatch announced the publication of its Phase III clinical study in Neurology Open Access. - The study evaluated an Apple Watch-based app designed to detect tonic-clonic seizures in people ages 5 and up. - The multicenter trial enrolled 242 participants undergoing video-EEG monitoring. - The study ran across six epilepsy monitoring units, including Johns Hopkins, LeBonheur Children’s, Thomas Jefferson, Children’s National and Johns Hopkins All Children’s.

The details: - EpiWatch reported 98% sensitivity, detecting 46 of 47 clinically verified tonic-clonic seizures. - The false alarm rate was 0.08 per 24 hours. - All tonic-clonic seizures during sleep were detected. - Results were consistent across pediatric and adult participants. - The study used blinded expert review to benchmark EpiWatch detections against seizure events. - The study’s primary endpoints were sensitivity and false alarm rate per 24 hours. - Secondary endpoints included detection latency and performance during sleep. - The trial was a prospective, multicenter Phase III diagnostic accuracy study led by Johns Hopkins epileptologists Nathan Crone, MD, and Greg Krauss, MD. - EpiWatch is FDA-cleared for use with Apple Watch and is designed for continuous seizure monitoring. - The company said the app showed safety and effectiveness in a consumer wearable format, with latency and sensitivity results comparable to other devices and a lower false alarm rate. - The full text of the study is available here.

Between the lines: - The strongest commercial implication is that a widely used smartwatch may be able to deliver clinically validated seizure alerts without drawing attention or adding stigma. - The low false alarm rate matters because frequent false alerts can undermine caregiver trust and slow adoption. - Real-world analysis is still ongoing, so the current data reflect controlled epilepsy monitoring unit settings rather than everyday use.

What’s next: - EpiWatch said real-world analysis is underway to evaluate performance in daily settings. - Broader uptake will likely depend on whether the trial results hold up outside the monitoring unit. - The company is positioning the app as a safety tool for patients, caregivers and clinicians managing tonic-clonic seizures.

The bottom line: - EpiWatch now has Phase III evidence that its Apple Watch-based seizure detection app can combine high sensitivity with a low false alarm rate in a controlled clinical setting.