EpiWatch

EpiWatch operates at the intersection of digital therapeutics, wearable medical devices, epilepsy monitoring, and mobile health. Its core differentiation is a prescription-based Apple Watch and iPhone experience that passively detects tonic-clonic seizures, sends real-time caregiver alerts, and can provide GPS location information. The company also emphasizes clinical testing, including a prospective Phase III study involving children and adults, and received FDA 510(k) clearance in March 2025. That combination distinguishes EpiWatch from general-purpose personal safety apps, manual seizure diaries, and conventional clinical monitoring workflows that may require dedicated hardware or retrospective reporting. Its dependence on Apple Watch hardware creates both a focused distribution advantage and a platform constraint. Direct App Store availability from September 2025 and standalone cellular-watch functionality announced in March 2026 broaden the addressable use case while preserving the company’s emphasis on caregiver communication and continuous monitoring.

EpiWatch shows a staged progression from early financing and product development to regulated commercialization. The company raised $2.16 million across five recorded rounds between May 2021 and July 2024, comprising three convertible notes, one seed round, and another convertible note. The largest recorded round was $650,000 on Jul 11, 2024. Teresa Prego became CEO in April 2024, preceding the company’s regulatory and commercial milestones. FDA 510(k) clearance in March 2025 marked the key inflection point from development toward market access. The application then became available for direct download in September 2025, while prescription activation preserved a clinician-mediated model. In March 2026, standalone functionality for cellular-enabled Apple Watch devices reduced reliance on a nearby iPhone and potentially simplified use during emergencies. Publication of a Phase III study in May 2026 added clinical evidence to the commercialization narrative. The current employee range of one to ten also suggests a lean operating structure.