EpiWatch Secures FDA Clearance for Apple Watch Seizure Monitoring App

The seizure detection app offers additional features, including medication reminders, seizure logging, and mental health screening for depression and anxiety. 

EpiWatch, a digital health company spun out from Johns Hopkins, has received US Food and Drug Administration (FDA) 510(k) clearance for its seizure monitoring platform. 

The Apple Watch-powered application is designed to detect and alert users about tonic-clonic seizures, commonly known as grand mal seizures. These can cause loss of consciousness and severe muscle contractions.

The seizure detection app offers additional features, including medication reminders, seizure logging, and mental health screening for depression and anxiety. The clearance allows EpiWatch to advance its wearable health technology for individuals living with epilepsy.

"This marks a significant step forward in fulfilling our mission to empower all people living with epilepsy and deliver innovation that keeps people with epilepsy safe and enables them, their caregivers, and their clinicians to better manage their condition while providing peace of mind for their caregivers and loved ones," said Teresa Prego, CEO of EpiWatch.

EpiWatch will initially work with clinicians and early users in a limited market release to refine the product and assess users' educational and support needs.

FDA Expands Approvals for Wearable Healthtech

The FDA has been increasingly approving wearable health technologies to improve patient care. 

In February, Google received FDA clearance for its AI-powered loss of pulse detection feature in the Pixel Watch 3. The technology monitors an individual’s pulse and, if no pulse is detected, activates sensors and a motion detector before automatically calling emergency services.

In September, Apple received FDA approval for two major health-related features:

Sleep apnea detection in Watch Series 10 uses an accelerometer and software algorithms to track breathing disturbances over multiple sleep sessions.

Over-the-counter hearing aid software embedded in AirPods Pro allows users to take a five-minute hearing test on their iPhone, after which the AirPods automatically adjust sounds to their specific hearing needs.

These approvals reflect a broader shift toward wearable health technologies critical in monitoring and managing medical conditions.

Regulatory Developments in Digital Health

The FDA has been actively updating its regulatory framework for digital health technologies. In 2022, the agency finalized a rule permitting over-the-counter hearing aids, expanding accessibility to hearing-impaired individuals. 

These regulatory changes align with the increasing role of consumer wearables in healthcare management, enabling early detection and intervention for various medical conditions.

With EpiWatch’s FDA clearance, wearable technology continues to expand its role in epilepsy care, potentially improving the quality of life for individuals with seizure disorders.