Seizure Detection Tech Receives FDA 510(k) Clearance

Image credit: Epitel

Digital health company, Epitel has received 510(k) clearance from the US Food and Drug Administration (FDA) for two new technologies for patients with seizures: the REMI Remote EEG Monitoring System for Ambulatory Use, and REMI Vigilenz AI For Event Detection.

REMI Ambulatory is a wireless system use enabling the recording of EEG [electroencephalogram] in patients’ homes across an extended period, while the Vigilenz AI [artificial intelligence] system assists clinicians in reviewing EEG recordings using machine learning (ML) to detect areas which could correspond to electrographic seizures.

“Existing EEG monitoring systems have been cumbersome and restrictive for patients, and technical requirements and limitations have impeded providers’ ability to administer, record, and interpret EEG,” said Epitel Chief Executive Officer and Co-founder, Mark Lehmkuhle in a statement.

“We are excited about how these two advances will shift the paradigm of brain health monitoring.”

Epitel said it is hoped the new platforms will be available to patients in selected sites later this year.

For further information, refer to the press release from Epitel.