Following FDA approval a few weeks ago, EpiWatch, a seizure monitoring app developed for the Apple Watch continues to generate momentum as it prepares for broader clinical integration. Created by a team at Johns Hopkins University, the app received 510(k) clearance from the U.S. Food and Drug Administration, allowing it to be marketed as a medical device for people living with epilepsy.

EpiWatch is designed to detect and alert users to tonic-clonic seizures (also known as grand mal seizures). It also includes supportive features such as medication reminders, seizure logs and screening tools for anxiety and depression, making it more than just a monitoring tool, but a comprehensive digital companion for epilepsy care.

The app uses Apple’s ResearchKit platform to collect health data, analyze seizure patterns and offer insights into possible triggers. This data can be shared with healthcare providers to improve treatment planning and patient outcomes.

Teresa Prego, CEO of EpiWatch, emphasized the broader mission:

“This is a major step in helping people with epilepsy take back control. EpiWatch is about safety, empowerment and easing the daily burden of managing a chronic condition for patients and their loved ones.”

Currently, the company is conducting a limited market release, working with clinicians and select users to fine-tune the platform and enhance support systems before full-scale launch.

The FDA’s clearance of EpiWatch highlights the increasing value of wearable health technologies in managing chronic diseases, promoting early intervention and personalizing patient care.

Disclaimer: This article is intended for informational purposes only and should not be considered medical advice. Please consult a qualified healthcare provider for personal health decisions or treatment options.