BioSerenity Achieves FDA Clearance for Wearable Device System

BioSerenity Inc., a global provider of remote diagnostic solutions in the areas of Neurology, Cardiology and Sleep Disorders has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Neuronaute EEG System and IceCap EEG wearable device that will allow physicians to remotely monitor and assess electrical brain activity of people living with epilepsy.
 
One in 26 people will develop epilepsy or recurrent seizures during their lifetime. Due to the complexity of providing long term testing, many patients have limited access to care. Together, the IceCap and Neuronaute system are a unique and ideal combination to facilitate access to care in a variety of settings including rural and remote environments.
 
The Neuronaute system assists healthcare professionals in the diagnosis, monitoring and assessment of epilepsy and other neurological disorders in adult patients. The system consists of hardware and software that acquires, displays, stores, archives, and transmits EEG signals from the brain using a full 10-20 montage. Remote access is facilitated via the Neuronaute N-CLOUD which receives EEG signals from the Neuronaute Head Module which then transmits to the cloud. This proprietary design enables physician review and interpretation at an office, hospital, or other remote location. 
 
The IceCap (Immediate Care Encephalography) Cap is a wearable medical device used together with the Neuronaute system. It is a single-use disposable electrode cap that quickly and easily enables the recording of short interval (less than 1 hour) EEG for routine or emergency brain activity assessments.
 
“BioSerenity is committed to improving patient care by making EEG diagnostics more readily available to the 3.4 million people in the USA alone who are living with epilepsy,” said 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 neurological specialists anytime and anywhere.”
 
Pierre-Yves Frouin, BioSerenity CEO, added, “This is an exciting milestone for BioSerenity and demonstrates our commitment to bring world class medical devices and technological solutions to the market.”