Summary: Epitel announced FDA clearance for two technologies: REMI Remote EEG Monitoring System for home use and REMI Vigilenz AI for Event Detection, enhancing outpatient EEG monitoring and seizure detection through advanced AI.

Key Takeaways:

  • FDA approval for home EEG monitoring and AI-driven event detection.
  • Improved patient comfort and continuous monitoring at home.
  • REMI Vigilenz AI uses machine learning for precise seizure analysis.

Epitel announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearances for the REMI Remote EEG Monitoring System for Ambulatory use and the REMI Vigilenz AI for Event Detection.

Enhancing EEG Monitoring at Home

The REMI for Ambulatory use is designed for EEG recording in outpatient and home settings over extended periods. This technology allows patients monitor their health without the restrictions of traditional wired systems. It uses REMI Sensors combined with a mobile computing platform that enables patients and caregivers to mark when an event or suspected event occurs over an extended period.

Advanced AI for Event Detection

REMI Vigilenz AI for Event Detection uses advanced machine learning algorithms to analyze and mark REMI EEG records for potential electrographic seizures, enhancing the accuracy and ease of interpretation. This AI system categorizes seizure-like events with varying levels of confidence, significantly speeding up the diagnostic process.

Regulatory and Future Plans

The FDA also approved a Predetermined Change Control Plan for REMI Vigilenz AI, allowing Epitel to continually improve the technology’s effectiveness in seizure detection. These innovations are expected to be available through select practices later this year, promising better clinical care through more precise and patient-friendly monitoring solutions.

“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. REMI Ambulatory and REMI Vigilenz AI For Event Detection will help patients and providers make better-informed treatment decisions,” said Mark Lehmkuhle, PhD, chief executive officer and co-founder of Epitel. “We are excited about how these two advances will shift the paradigm of brain health monitoring.”