Summary: Epitel’s REMI Vigilenz AI For Bedside Notifications has received FDA 510(k) clearance. This system provides near real-time analysis of EEG data, notifying clinicians of potential seizures. The clearance includes an authorized Predetermined Change Control Plan (PCCP), allowing future performance updates without additional FDA review.

Key Takeaways:

  • REMI Vigilenz AI For Bedside Notifications improves seizure detection at the bedside by providing near real-time EEG analysis and notifications.
  • The FDA’s clearance with a PCCP allows Epitel to make future updates to the device without further FDA review, demonstrating its leadership in brain health technology.

Epitel, a provider of AI for patient-focused brain health technologies, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for REMI Vigilenz AI For Bedside Notifications.

Automated EEG Analysis and Seizure Detection

REMI Vigilenz AI For Bedside Notifications 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.

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, according to the company. 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.

RELATED: FDA Clears Epitel’s REMI Technologies for EEG Monitoring

Improving Seizure Detection in Hospitals

“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,” said Mark Lehmkuhle, PhD, founder and chief executive officer of Epitel. “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, demonstrating Epitel’s position at the forefront of brain health technology.

Previous Regulatory Clearances

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.