Epitel Expands AI Portfolio With Fourth FDA 510(k) Clearance for REMI

Epitel has received U.S. Food and Drug Administration (FDA) 510(k) clearance 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.

Notifications occur when the algorithm recognizes seizure characteristics within a section of EEG. These notifications provide information about the potential electrographic seizure, including seizure burden and corresponding confidence level.

Neurologists trained in reading EEGs are highly specialized and often only available in the largest medical facilities. This can leave patients vulnerable to delays in the proper identification of seizures, which may impact patient outcomes. The REMI platform enables more patients to be monitored for days at a time across healthcare facilities that may not have traditional EEG equipment and specialized EEG technicians, increasing the likelihood of detecting a seizure. With REMI Vigilenz AI For Bedside Notifications, there is now the potential for bedside clinicians to rapidly identify seizures in the hospital by pinpointing regions of potentially abnormal EEG.

“Identifying seizures at the point-of-care is still a major challenge for hospitals of all sizes. This is especially critical for hospitals without 24/7 EEG coverage and for those that lack the resources for after-hours, weekend, and holiday coverage,” Epitel Founder/CEO Mark Lehmkuhle, Ph.D., said. “With REMI Vigilenz AI For Bedside Notifications, clinicians will be notified of the occurrence of potential seizures, which can reduce time to treatment and improve outcomes for patients in the smallest of clinics to the largest of hospitals.”

The FDA cleared REMI Vigilenz AI For Bedside Notifications with an authorized Predetermined Change Control Plan (PCCP), a new program permitting Epitel to implement predetermined performance-enhancing updates to the device without further FDA review. This is Epitel’s second AI/ML medical device cleared by the FDA and is also Epitel’s second device with an authorized PCCP.

In May 2024, REMI Vigilenz AI For Event Detection received regulatory clearance and authorized PCCP status. REMI Vigilenz AI For Event Detection is currently being commercialized alongside REMI Remote EEG Monitoring System for Ambulatory (at-home) Use.

REMI Vigilenz AI For Bedside Notifications is a seizure detection module that is integrated into the REMI Remote EEG Monitoring System and is only indicated for use within non-ICU healthcare settings. REMI Vigilenz AI For Bedside Notifications has not been validated for and is not indicated for the detection of electrographic status epilepticus.

REMI Vigilenz AI For Bedside Notifications conducts automated analysis of REMI EEG data in near real-time and provides notifications of potential electrographic seizures (events) through the REMI System when seizure prevalence of 10% or greater (indicating seizure activity of at least 30 seconds within a five-minute rolling window) is detected. When seizure prevalence is displayed, the notification also displays the corresponding event detection confidence.

The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses 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 up to 30 days.

The REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-shelf mobile computing platforms. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software.

Epitel is a digital health company modernizing brain health solutions. By leveraging a proprietary cloud-based wearable sensor system and other innovative AI technologies, Epitel is empowering more informed treatment decisions by making EEG readily deployable and accessible with an initial focus on improving seizure monitoring and detection.