The Johns Hopkins-born company EpiWatch has received FDA 510(k) clearance for its continuous seizure monitoring platform that leverages Apple Watch technology to detect and alert for tonic-clonic seizures, also known as grand mal seizures.

The newly cleared platform offers comprehensive epilepsy management features through an Apple Watch app that reminds users to take medications, provides seizure trigger insights, screens for mental health conditions like depression and anxiety, and enables seizure logging. This innovation represents the culmination of long-term collaborative efforts 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.

The company has announced plans for a limited market release, working directly with clinicians and early adopters to optimize the product's usage and identify key educational and support requirements for users.

This development aligns with the broader trend of wearable technology evolving to monitor health metrics and predict potential medical issues. Other recent advancements in this space include Google's FDA clearance for AI-enabled loss of pulse detection on its Pixel Watch 3, which can detect pulse absence and automatically alert emergency services if necessary.

Apple has similarly expanded its healthcare capabilities, receiving FDA clearance for sleep apnea detection in its Watch Series 10 and over-the-counter hearing aid functionality in AirPods Pro. The sleep apnea feature measures breathing disturbances during sleep to identify moderate to severe sleep apnea risk, while the AirPods Pro use machine learning to function as clinical-grade hearing aids after users complete a five-minute hearing test.

These developments follow the FDA's 2022 final rule allowing access to over-the-counter hearing aids and related regulatory framework updates, creating opportunities for more consumer health products to enter the medical device space.

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