BioSerenity’s EEG Monitoring System Gets FDA Clearance

January 7, 2021

BioSerenity’s electroencephalography (EEG) monitoring system and accompanying wearable cap have been given 510(k) marketing clearance for monitoring and assessing the brain activity of epileptic patients.

The agency cleared the Neuronaute EEG system, a platform that can monitor, diagnose and assess epilepsy and other neurological disorders, as well as IceCap, a single-use disposable electrode cap that records short-interval brain activity.

The platform transmits EEG signal data to a cloud system, enabling physicians to remotely review and interpret the readings.

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