FDA Clears Wearable Remote EEG System

The Food and Drug Administration (FDA) gave 510(k) clearance for a remote EEG wearable device (Neuronaute; Icecap; BioSerenity, Atlanta, GA) that will allow physicians to remotely monitor and assess electrical brain activity of individuals as they continue their daily activities. Considering the complexity of providing long term testing, the system and device are a unique and ideal combination to facilitate access to care in a variety of settings. 

The  single-use disposable electrode cap quickly and easily enables the recording of short-interval 10- or 12-channel EEG (<60 minutes) for routine or emergency brain activity assessments. 

The system assists providers in the diagnosis, monitoring and assessment of epilepsy and other neurologic disorders. The system includes hardware and software that acquires, displays, stores, archives, and transmits EEG signals from the brain using a full 10 to 20 montage. This proprietary design enables physician review and interpretation at an office, hospital, or other remote location.

"BioSerenity is committed to improving patient care by making EEG diagnostics more readily available to the 3.4 million people in the US alone who are living with epilepsy," according to BioSerenity chief medical officer Bruce Lavin, MD, MPH. "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 neurologic specialists anytime and anywhere."  Pierre-Yves Frouin, BioSerenity chief executive officer adds, "This is an exciting milestone for BioSerenity and demonstrates our commitment to bring world class medical devices and technological solutions to the market."