The US FDA has given 510(k) clearance to BioSerenity’s Neuronaute EEG system and IceCap EEG wearable device that will allow physicians to monitor and assess remotely electrical brain activity of people living with epilepsy.

Headquartered in Paris, France, and Atlanta, Georgia, BioSerenity provides remote diagnostic products in the areas of neurology, cardiology and sleep disorders.

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 facilitate access to care in various settings including rural and remote environments.

The Neuronaute helps healthcare professionals in the diagnosis, monitoring and assessment of epilepsy and other neurological disorders in adult patients. The system’s hardware and software acquire, display, store, archive 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 a head module that 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) is a wearable medical device used with Neuronaute. It is a single-use disposable electrode cap that quickly and easily enables the recording of short interval – less than one 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. “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 technology to the market.”

BioSerenity is a medical technology company focused on healthcare-as-a-service, IoMT, AI and real-world evidence in neurology, sleep medicine and cardiology. It provides remote diagnostic products to healthcare providers and patients in the USA, Europe and Caribbean.