FDA Clears Wearable EEG Device System

The US Food and Drug Administration (FDA) gave a 510(k) clearance to the Neuronaute® electroencephalogram (EEG) System and IceCap® EEG wearable device system for use among patients with epilepsy.

According to the manufacturer, BioSerenity, Inc., this device system enables physicians to diagnose, monitor, and assess their patients’ electrical brain activity remotely.

"With FDA clearance to market the Neuronaute® system and IceCap®, we can deliver high-quality, cost-effective diagnostic care by remotely connecting patients in need with neurological specialists anytime and anywhere."  says CEO of BioSerenity, Pierre-Yves Frouin, in a press release.

—Christina Vogt

Reference:
BioSerenity announces FDA clearance for electroencephalography (EEG) wearable device system. News release. BioSerenity, Inc. January 5, 2021. Accessed January 6, 2021. https://www.biospace.com/article/releases/bioserenity-announces-fda-clearance-for-electroencephalography-eeg-wearable-device-system/