EpiWatch wins FDA clearance for Apple Watch seizure management app

EpiWatch, the Apple Watch-based epilepsy management company spun out from Johns Hopkins, announced it received FDA 510(k) clearance for its continuous seizure monitor platform that utilizes the popular wearable to detect and alert for tonic-clonic seizures.

Tonic-clonic seizures, or grand mal seizures, are a type of seizure that affects the whole brain and can cause violent muscle contractions and sudden loss of consciousness. 

EpiWatch’s seizure detection app on the Apple Watch provides individuals with monitoring technology that reminds them to take their medication, provides insights on what triggers a seizure, screens for depression and anxiety, and allows for logging seizures. 

The product is part of a long-term collaboration between Johns Hopkins Medicine and EpiWatch using Apple’s ResearchKit platform.  

“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,” Teresa Prego, EpiWatch CEO, said in a statement. 

“EpiWatch will now partner with clinicians and early users for a limited market release aimed at optimizing product use and identifying and understanding key educational and support needs for EpiWatch users.”

THE LARGER TREND

Wearables have increasingly been used to monitor consumers’ health metrics and predict potential health issues.

In February, tech giant Google received FDA clearance for its AI-enabled loss of pulse detection technology feature available on the Pixel Watch 3. 

The feature checks for an individual’s pulse, and once it detects signs of a loss of pulse, the device activates infrared and red lights to search for additional pulse signals. A motion sensor then checks for signs of movement, and if a loss of pulse is confirmed, the watch triggers a countdown to see if the user responds. 

If no pulse is detected, the watch calls emergency services and sends an automated message to alert the operator of the user’s status and location. 

In September, Apple received FDA clearance for the sleep apnea feature in its Watch Series 10 and over-the-counter hearing aid software embedded in its AirPods Pro headphones. 

The Watch Series 10 sleep apnea feature measures whether a user has moderate to severe sleep apnea based on a metric called Breathing Disturbances. The device uses software algorithms and the accelerometer to analyze signals gathered over multiple sleep sessions to determine if the wearer is at risk for sleep apnea. 

The company’s AirPods Pro headphones include clinical-grade over-the-counter hearing aids that use machine learning to adjust noises to users’ hearing needs automatically. 

Wearers take a five-minute test using their iPhone and AirPods Pro to analyze their hearing health, and based on the results of that test, the AirPods automatically adjust to a user’s hearing needs, serving as a clinical-grade hearing aid.  

In 2022, the FDA issued a final rule to allow access to over-the-counter hearing aids and made related amendments to update the regulatory framework.

EpiWatch, the Apple Watch-based epilepsy management company spun out from Johns Hopkins, announced it received FDA 510(k) clearance for its continuous seizure monitor platform that utilizes the popular wearable to detect and alert for tonic-clonic seizures.

Tonic-clonic seizures, or grand mal seizures, are a type of seizure that affects the whole brain and can cause violent muscle contractions and sudden loss of consciousness. 

EpiWatch’s seizure detection app on the Apple Watch provides individuals with monitoring technology that reminds them to take their medication, provides insights on what triggers a seizure, screens for depression and anxiety, and allows for logging seizures. 

The product is part of a long-term collaboration between Johns Hopkins Medicine and EpiWatch using Apple’s ResearchKit platform.  

“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,” Teresa Prego, EpiWatch CEO, said in a statement. 

“EpiWatch will now partner with clinicians and early users for a limited market release aimed at optimizing product use and identifying and understanding key educational and support needs for EpiWatch users.”

THE LARGER TREND

Wearables have increasingly been used to monitor consumers’ health metrics and predict potential health issues.

In February, tech giant Google received FDA clearance for its AI-enabled loss of pulse detection technology feature available on the Pixel Watch 3. 

The feature checks for an individual’s pulse, and once it detects signs of a loss of pulse, the device activates infrared and red lights to search for additional pulse signals. A motion sensor then checks for signs of movement, and if a loss of pulse is confirmed, the watch triggers a countdown to see if the user responds. 

If no pulse is detected, the watch calls emergency services and sends an automated message to alert the operator of the user’s status and location. 

In September, Apple received FDA clearance for the sleep apnea feature in its Watch Series 10 and over-the-counter hearing aid software embedded in its AirPods Pro headphones. 

The Watch Series 10 sleep apnea feature measures whether a user has moderate to severe sleep apnea based on a metric called Breathing Disturbances. The device uses software algorithms and the accelerometer to analyze signals gathered over multiple sleep sessions to determine if the wearer is at risk for sleep apnea. 

The company’s AirPods Pro headphones include clinical-grade over-the-counter hearing aids that use machine learning to adjust noises to users’ hearing needs automatically. 

Wearers take a five-minute test using their iPhone and AirPods Pro to analyze their hearing health, and based on the results of that test, the AirPods automatically adjust to a user’s hearing needs, serving as a clinical-grade hearing aid.  

In 2022, the FDA issued a final rule to allow access to over-the-counter hearing aids and made related amendments to update the regulatory framework.