EpiWatch, Inc. Announces Publication of Landmark Phase III Study in Neurology Open Access

Apple Watch®–based tonic clonic seizure detection for ages 5 and up demonstrates high seizure detection accuracy with low False Alarm Rate (FAR).

BALTIMORE, MD, UNITED STATES, May 28, 2026 /EINPresswire.com/ -- EpiWatch today announced the publication of its Phase III clinical study in Neurology Open Access, demonstrating strong performance of its Apple Watch–based seizure detection application in identifying tonic-clonic seizures (TCS) across pediatric and adult populations ages 5 and up.
Over 3.5 million Americans are impacted by epilepsy. Injury related to seizures and Sudden Unexpected Death in Epilepsy (SUDEP) remain critical risks for individuals with uncontrolled or poorly controlled seizures—especially those who sleep alone. Recent clinical guidelines published by the International League Against Epilepsy (ILAE) recommend consideration of wearable devices for tonic clonic seizure detection and alerting to help reduce this risk.

Seizure detection allows caregivers to respond to seizures quickly, helping to protect people with epilepsy from injury or harm related to tonic clonic seizures.
EpiWatch is a clinically validated and FDA-cleared app for use with Apple Watch designed to detect tonic clonic seizures (TCS) with a low false alarm rate (FAR). This phase III clinical trial was designed to evaluate and clinically validate sensitivity and false alarm rates for participants across six epilepsy monitoring units in a large multi-center study. EpiWatch successfully demonstrated high sensitivity (98%) and a low False Alarm Rate (.08/24 hours).

Key Findings include:
• 98% Sensitivity: EpiWatch detected 46 of 47 clinically verified tonic clonic seizures (TCS) (95% CI, 95%–100%)
• Low False Alarm Rate: 0.08 false alarms per 24 hours (95% CI, 0.02–0.12)
• Strong Performance During Sleep: 100% of tonic-clonic seizures during sleep were detected
• Consistent Across Age Groups: Comparable results in both pediatric and adult participants

The study enrolled 242 participants aged 5 years and older undergoing video-EEG monitoring. EpiWatch detections were benchmarked against seizure events independently reviewed by a blinded panel of expert reviewers.
“This publication marks a major milestone in establishing EpiWatch as a clinically validated platform for seizure detection and alerting,” said Teresa Prego, CEO of EpiWatch. “By significantly reducing false alarms while maintaining high sensitivity, and running on a consumer-friendly wearable platform, we are addressing some of the current barriers to adoption of seizure detection devices and enabling greater trust among patients, caregivers, and clinicians. The ability to respond quickly to a tonic clonic seizure is important, both for people with epilepsy and their caregivers and families.”

Advancing Seizure Detection Technology
In clinical validation, EpiWatch demonstrated the safety and effectiveness of a continuous seizure monitoring app for a widely adopted consumer wearable, with sensitivity and latency results comparable to other devices while exhibiting a lower FAR.
The application leverages the widespread adoption and familiarity of the Apple Watch, offering a discreet, consumer-friendly solution designed to enhance safety for individuals living with epilepsy.
EpiWatch co-founder and principal investigator Greg Krauss, M.D., an epileptologist at Johns Hopkins Medicine related, “EpiWatch was specifically developed for use on Apple Watch, a widely adopted consumer device that does not draw unwanted attention or risk stigma. The study showed EpiWatch is reliable (high detection accuracy) without being disruptive (a low FAR). We are very pleased that we were able to validate this performance on the easily worn Apple Watch platform.”

About the Study
• Design: The study was a prospective, multicenter Phase III diagnostic accuracy study, led by Johns Hopkins Epileptologists Nathan Crone, MD and Greg Krauss, MD
• Population: Children and adults (≥5 years) with a history or risk of tonic clonic seizures were included
• Setting: Six epilepsy monitoring units, including Johns Hopkins, LeBonheur Children’s, Thomas Jefferson, Children’s National and Johns Hopkins All Children’s
• Primary Endpoints: Sensitivity (positive percent agreement) and false alarm rate per 24 hours
• Secondary Endpoints: Detection latency and performance during sleep
Results were obtained in controlled epilepsy monitoring unit environments (the current standard for seizure detection validation). Current real-world analysis is ongoing to evaluate performance in everyday settings.
View the full text of the study at https://doi.org/10.1212/WN9.0000000000000111

Teresa Prego
EpiWatch, Inc.
tprego@epiwatch.com
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