FDA-Cleared Next-Gen Epilepsy Wearable Launches in US

Image credit: Empatica

A next-gen medical watch designed to detect seizures in adults and children over age six with epilepsy has launched in the US.

Empatica’s EpiMonitor, cleared by the US Food and Drug Administration (FDA) and a successor to its Embrace2 device, combines a watch with a smartphone app and artificial intelligence (AI) to provide continuous, unobtrusive health monitoring.

The device is designed to detect and provide alerts when the wearer experiences possible generalised tonic-clonic seizures, and delivers health data via advanced sensor technology to help manage the patient’s epilepsy symptoms.

Empatica has touted the EpiMonitor as the only wearable solution with FDA regulatory clearance for seizure detection available to buy in the US.

December last year saw the company announce a new study to develop a seizure forecasting algorithm, based on what it called the world’s largest real-world data set in epilepsy patients. Recruitment of participants is now underway via US-based EpiMonitor users.

“EpiMonitor is the device we’ve long dreamed of to open a new era in giving epilepsy patients greater control over their lives,” said Empatica Chief Scientist and Co-founder, Dr Rosalind Picard in a press statement.

“…at the touch of a button, patients can now see comprehensive health insights – including seizures, sleep, and activity reports – in a form easy to give their clinician.”

Check out the full announcement from Empatica for further details, or watch the below video to see the tech in action.