BioSerenity Announces FDA Clearance for Electroencephalography (EEG) Wearable Device System


PARIS and ATLANTA, Jan. 5, 2021 /PRNewswire/ -- BioSerenity, Inc., a leading global provider of remote diagnostic solutions in the areas of Neurology, Cardiology and Sleep Disorders announced today it 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 Neuronaute® 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," 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 neurological specialists anytime and anywhere."  Pierre-Yves Frouin, BioSerenity CEO adds, "This is an exciting milestone for BioSerenity and demonstrates our commitment to bring world class medical devices and technological solutions to the market."

About BioSerenity, Inc.

Headquartered in Paris, France and Atlanta, GA, USA, BioSerenity is an innovative medical technology company focused on Healthcare as a Service, IoMT, A.I. and real-world evidence in Neurology, Sleep Medicine, and Cardiology. BioSerenity provides remote diagnostic solutions to healthcare providers and patients in the US, Europe and Caribbean. BioSerenity is also the preferred provider for several Contract Research Organizations and prominent university medical facilities across the US, France, and other parts of the world.  For more information, please visit   


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SOURCE BioSerenity, Inc.


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