Epitel’s REMI Wireless EEG Wins FDA Nod for Patients Age 1 and Up

Epitel, a company specializing in artificial intelligence (AI)-driven brain health solutions, has gained another U.S. Food and Drug Administration (FDA) 510(k) clearance for its REMI wireless EEG system.

The new FDA nod expands REMI’s indication to infants and children one year and older. Epitel said the designation underscores REMI’s potential to revolutionize neurological monitoring in a particularly vulnerable patient population.

Conventional electroencephalography (EEG) monitoring usually has cumbersome equipment and wires, which can be distressing to a child in need of care and their family. REMI overcomes this with a wire-free design so young children don’t pull on wires or displace electrodes that could disrupt data integrity.

It leverages single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration of up to 30 days. An accompanying software application runs on qualified, commercial, off-the-shelf mobile computing platforms.

This latest FDA nod marks the company’s fifth 510(k) clearance for REMI, which was first cleared by the agency in March 2021. The previous clearance was for REMI Vigilenz AI For Bedside Notifications, a device that conducts an automated analysis of EEG data collected by the REMI wireless wearable EEG System in near real-time.

“Epitel continues to make EEG monitoring accessible and deployable for all communities. This new clearance reflects our commitment to improving brain health across all age groups, demographics, and geographies, ensuring that even the youngest patients receive timely and accurate care,” said Steve Pacelli, the newly appointed CEO of Epitel.