Neurosteer Single-Channel EEG Platform Cleared by FDA

Nathan Intrator, PhD

The FDA has given clearance to the Neurosteer single-channel electroencephalogram (EEG) brain monitoring platform, Neurosteer announced, allowing for the multipurpose system to be utilized in a wide variety of clinical settings.¹

The platform, which the company calls “unobtrusive,” is able to be used for continuous brain monitoring to support critical intervention in the intensive care unit (ICU), as well as in office visits for the detection of presymptomatic cognitive decline related to diseases such as Alzheimer disease, Parkinson disease, and dementia. Neurosteer noted in its announcement that the platform can also be used in clinical trials for pharmaceutical therapeutics, assisting in cost-effective and speedy mass screening of those with neurodegenerative diseases.

“After working with the Neurosteer EEG system for several years, I've realized what an advantage it is to have a compact, easy-to-apply EEG brain monitor that can be used for real-time continuous monitoring. Neurosteer's innovative platform has the potential to revolutionize the standard of care in managing brain health,” Amitai Bickel, MD, surgeon and faculty of medicine, Western Galilee Hospital, Bar-Ilan University, in Safeed, Israel, said in a statement.¹

Data published in Frontiers in Aging Neuroscience in 2022 from a study (NCT04386902) of 60 individuals conducted by Nathan Intrator, PhD, founder and CEO, Neurosteer, and colleagues,² suggested that the EEG platform could successfully assess cognitive states with an auditory cognitive assessment. Intrator and colleagues wrote that “the short set-up time and novel [machine-learning] features enable objective and easy assessment of cognitive states.” Ultimately, the data showed that there was significant correlation between Mini-Mental State Examination (MMSE) scores and reaction times and EEF features A0 and ST4. Notably, EEG features Theta, Delta, A0, and VC9 all displayed increased activity with higher cognitive load levels—which was present only in the healthy young group—suggestive of different activity patterns between young and senior participants in different cognitive states. Intrator et al wrote that this association was most prominent for VC9, which significantly separated between all level of cognitive load.²

"We are extremely pleased that the FDA has cleared our portable and affordable EEG system, and moreover, recognized the potential clinical value of our brain metrics visual representations. This is an important step in achieving our goal of making brain monitoring and assessment widely available to all populations,” Intrator said in a statement.¹

The platform uses an adhesive electrode forehead strip that connects to a small, wireless sensor that transmits to the cloud. The FDA has cleared the system to also include several novel "brain metrics" visual representations, which rely on its advanced signal processing and “may assist trained medical staff in making neurological diagnoses,” according to the company. The system comes with a noninvasive assessment with auditory prompts that can aid in the early detection of brain deterioration.

Additional data using the system, published in 2016 in PLoS One by Intrator et al, suggested that an EEG prediction model of amygdala active from a single electrode “can overcome substantial limitations of [functional magnetic resonance imaging-based neurofeedback]. It can enable investigation of [neurofeedback] training using multiple sessions and large samples in various locations.”³

REFERENCES
1. Neurosteer Announces FDA Clearance of the Neurosteer EEG Brain Monitoring Platform. News release. Neurosteer. November 4, 2022. Accessed November 4, 2022. https://www.prnewswire.com/news-releases/neurosteer-announces-fda-clearance-of-the-neurosteer-eeg-brain-monitoring-platform-301668493.html
2. Molcho L, Maimon NB, Regev-Plotnik N, Rabinowicz S, Intrator N, Sasson A. Single-Channel EEG Features Reveal an Association With Cognitive Decline in Seniors Performing Auditory Cognitive Assessment. Front Aging Neurosci. 2022;14:773692. doi:10.3389/fnagi.2022.773692
3. Meir-Hasson Y, Keynan JN, Kinreich S, Jackont G, Cohen A, Podlipsky-Klovatch I, Hendler T, Intrator N. One-Class FMRI-Inspired EEG Model for Self-Regulation Training. PLoS One. 2016;11(5):e0154968. doi: 10.1371/journal.pone.0154968