EEG Wearable Device System FDA Approved for Epilepsy

Bruce Lavin, MD

BioSerenity has announced that the FDA has given 510(k) clearance for the Neuronaute EEG System and IceCap EEG wearable device, allowing clinicians the ability to remotely monitor and access electrical brain activity of patients with epilepsy.¹

The Neuronaute EEG system consists of hardware and software that acquires, displays, stores, archives, and transmits electroencephalogram (EEG) signals from the brain using a full 10–20 montage. This allows health care professionals with diagnosing, monitoring, and assessing adults with epilepsy and other neurologic disorders.

Clinicians can receive notifications of specific events related to the patient while looking at live data visualization. Additionally, there is an extended battery life of 8 hours with a rechargeable battery.²

“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,” Bruce Lavin, MD, MPH, chief medical officer, BioSerenity, said in a statement.¹

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Clinicians can use the Neuronaute N-CLOUD to review and interpret their patients at an office, hospital, or another remote setting. The system is designed to have the EEG signals sent directly from the Neuronaute Head Module which then transmits to the cloud.

In conjunction with the Neuronaute system, the IceCap (Immediate Care Encephalography) Cap is a wearable medical device in the form of a single-use disposable cap that enables the recording of short-interval EEG (less than 1 hour) for routine or emergency brain activity assessments.

"With the FDA-clearance to market Neuronaute system and IceCap, we can deliver high-quality, cost-effective diagnostic care by remotely connecting patients in need with neurological specialists anytime anywhere,” Pierre-Yves Frouin, chief executive officer, Bioserenity, said in a statement.

This addition to the space joins other wearable technologies in epilepsy, such as FORCE Technology’s ePatch wearable ECG device, which demonstrated its effect in a phase 2 study conducted by Jesper Jeppesen, PhD. The analysis suggested that wearable ECG devices may be a feasible method of seizure detection in patients with epilepsy and seizure disorders.

NeurologyLive recently spoke with Christian Meisel, MD, neurologist from Universitätsmedizin Berlin and Berlin Institute of Health, who presented data at the American Epilepsy Society (AES) Annual Meeting, December 4–8, 2020, on his study which evaluated the use of multi-modal wristband data to forecast seizures. In the video below, he discussed that data, what the treatment landscape looks like for these seizure forecasting devices, and the challenges associated with developing them.

REFERENCES

1. BioSerenity announces FDA clearance for electroencephalography (EEG) wearable device system. News release. BioSerenity. January 5, 2021. Accessed January 5, 2020. https://www.prnewswire.com/news-releases/bioserenity-announces-fda-clearance-for-electroencephalography-eeg-wearable-device-system-301200831.html

2. BioSerenity. https://www.bioserenity.com/en/neuro/. Accessed January 5, 2021.