Category: Medtech
A Johns Hopkins University epilepsy device spinout hasn’t brought its product to market yet, but there’s already a waitlist, thanks to a pair of trials.
EpiWatch has created an app for the Apple Watch that can detect seizures in patients with epilepsy, something CEO Teresa Prego said could revolutionize seizure monitoring and care if approved by the U.S. Food and Drug Administration. The traditional model of tracking seizures is time-consuming and often inaccurate. Patients are usually tasked with recording their own seizures and reporting them to the doctor regularly. EpiWatch is trying to change that.
"If you can track it on your Apple Watch, that’s huge for people — nobody wants to be reminded of their chronic conditions," Prego said.
The company has run a clinical trial of 300 patients and an ambulatory study of hundreds more in their natural environments, and many participants have said they want to keep using the app. The response was so overwhelming that Prego and the team decided to start keeping a list.
EpiWatch hopes to submit its materials for FDA approval under the software-as-medical-device category by the end of 2024. Then, it typically takes around 120 days to hear back. If EpiWatch gets the green light, the app could hit the market late in 2025, Prego said.
The product, created by Johns Hopkins neurologists Dr. Gregory Krauss and Dr. Nathan Crone, could help the roughly 3 million Americans with epilepsy monitor their symptoms more safely from the comfort of their homes.
"When we say [to patients] 'It's on an Apple Watch,' it’s a relief for them to know they can access this tool easily," Prego said.
In May, EpiWatch was awarded roughly $275,000 from the National Institutes of Health to research wearable monitoring technology for other forms of seizures. Prego thinks the door is open to help millions more.
