Epitel, a developer of artificial intelligence (AI) for brain health technologies, has received the US Food and Drug Administration (FDA) 510(k) clearance for REMI Vigilenz AI for Bedside Notifications.
REMI Vigilenz AI for Bedside Notifications is a seizure detection module integrated into the REMI Remote EEG Monitoring System. It is specifically designed for use in non-ICU healthcare settings.
This AI conducts an automated analysis of electroencephalogram (EEG) data from the REMI wireless wearable EEG system in near real-time.
REMI Vigilenz AI for Bedside Notifications is designed to send automated alerts when seizure characteristics are detected within a section of EEG.
These notifications include details about potential electrographic seizures, such as seizure burden and corresponding confidence levels.
The REMI platform facilitates extended monitoring of more patients in healthcare facilities lacking traditional EEG equipment and specialised EEG technicians. This increases the chances of detecting seizures.
With REMI Vigilenz AI for Bedside Notifications, clinicians can quickly identify seizures by pinpointing areas of potentially abnormal EEG in the hospital.
Additionally, the tool’s mobile app connects trained professionals with data from REMI Sensors, sending notifications and securely storing EEG data for review in the REMI Cloud.
Epitel founder and CEO Mark Lehmkuhle said: “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.
“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 has cleared REMI Vigilenz AI for Bedside Notifications under a Predetermined Change Control Plan (PCCP), which allows Epitel to make performance-enhancing updates to the device without additional FDA review.
The approval also marks Epitel’s second AI/ML medical device approved by the FDA and its second device with an authorised PCCP.
In May this year, REMI Vigilenz AI for Event Detection received regulatory clearance and authorised PCCP status. The AI system is being commercialised alongside the REMI Remote EEG Monitoring System for ambulatory (at-home) use.
