The FDA Clears Apple Watch-Powered Platform for Seizure Monitoring

The FDA Clears Apple Watch-Powered Platform for Seizure Monitoring. An EpiWatch monitoring a brain for seizures.

In a significant step forward for wearable health tech, — a Johns Hopkins Medicine spinout — has received for its seizure detection platform that runs on the Apple Watch. The platform is designed to continuously monitor for tonic-clonic (grand mal) seizures, a form of epilepsy that causes full-body convulsions and loss of consciousness.

EpiWatch’s Apple Watch-based app goes beyond detection, offering medication reminders, tracking potential seizure triggers, mental health screening and seizure logging. It's an important advance in remote patient monitoring for individuals living with epilepsy and is part of a long-term collaboration with Johns Hopkins Medicine, powered by Apple’s , Apple’s open-source software.

“This marks a significant step forward in fulfilling our mission to empower all people living with epilepsy,” said Teresa Prego, EpiWatch CEO. The company plans a limited market release to collaborate with clinicians and users and refine the platform’s support and education features.

Wearables increasingly are gaining FDA attention as tools for proactive health monitoring. In February, Google received clearance for an on the Pixel Watch 3. The Apple Watch Series 10 recently earned FDA clearance for , while its AirPods Pro 2 include — following the FDA’s 2022 rule enabling over-the-counter hearing aids.

For hospital leaders, these developments signal accelerating momentum behind wearable tech as a companion to clinical care, enabling more proactive, personalized health management and potentially easing the burden on emergency services and chronic disease management.

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