FDA clears Epitel remote monitoring tech, AI detection platform

Epitel has announced its reception of FDA 510(k) clearance for two novel patient-focused brain health solutions. The Remi remote EEG monitoring system, cleared for ambulatory use, and the Remi Vigilenz AI, designed for event detection, have both gained FDA approval. Remi's ambulatory feature facilitates extended EEG recording in outpatient and home settings, while Vigilenz AI utilises advanced machine learning to identify potential seizure events in Remi EEG records, with clearance under a predetermined change control plan (PCCP) by the FDA.

The Remi ambulatory feature offers an extended EEG monitoring experience within the comfort of one's home during daily activities. It employs the same sensors utilised in the healthcare facility version of the Remi platform, augmented with a mobile computing platform, allowing patients and caregivers to mark suspected events for further analysis.

Epitel developed Remi Vigilenz AI to leverage cutting-edge proprietary machine learning, enabling the identification and annotation of potential seizure events in Remi EEG records. The FDA clearance of the AI includes a predetermined change control plan (PCCP), facilitating adaptability for AI/ML-enabled devices.

Epitel plans to introduce both new platforms through select practices later this year, aiming to address limitations associated with existing EEG monitoring systems. Mark Lehmkuhle, CEO and co-founder of Epitel, expressed optimism regarding the potential of Remi ambulatory and Remi Vigilenz AI to enhance treatment decisions for patients and providers, foreseeing a transformative impact on brain health monitoring practices.

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