BioSerenity receives FDA clearance for EEG wearable device system

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BioSerenity has announced that its electroencephalography (EEG) wearable device system has received 510(k) clearance from the US Food and Drug Administration (FDA). This clearance includes BioSerenity’s Neuronaute EEG system and IceCap EEG wearable device, which are intended to allow physicians to remotely monitor and assess electrical brain activity of people living with epilepsy.

According to BioSerenity, one in 26 people will develop epilepsy or recurrent seizures during their lifetime, but due to the complexity of providing long-term testing, many patients have limited access to care. The company further claims that 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.

BioSerenity reports that 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. The company claims remote access is facilitated via the Neuronaute N-CLOUD which receives EEG signals from the Neuronaute Head Module which then transmits to the cloud.

BioSerenity’s chief medical officer Bruce Lavin (Atlanta, USA) commented, “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.” He continued, “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.”


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