FDA Clears Pediatric Version of NeuroCap EEG Headset

Irina Nazarova

Brain Scientific announced that the FDA has given 510(k) clearance for its next-generation NeuroCap electroencephalogram (EEG) headset device.¹

The NeuroCap is a pre-gelled disposable EEG headset with 22 electrodes and 19 active EEG channels that can be used for recording EEGs in neurology clinics, urban and rural emergency departments, intensive care units (ICUs), urgent care clinics, nursing homes, and a variety of other settings.

The fixed electrode placement is in accordance with the international 10-20 system and is compatible with another other encephalographs and amplifiers of EEG signals by the use of a special adapter. The process of placing electrodes and measuring the patient’s head is removed because of the cap’s pre-gelled fixed electrode locations. This also enables the use of the device by healthcare workers other than specialized neurological technicians.

"We are constantly working on new products for the EEG market. In the new version of NeuroCap, we added Velcro strips for better adhesion. We also expanded the size range by adding an XS (extra small) size. And now this device is designed for broader use – in addition to the intensive care units and ERs,” Irina Nazarova, marketing director, Brain Scientific, said in a statement.

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Brain Scientific previously submitted a premarket 510(k) application for FDA approval in October 2020 in an attempt to meet the neurological needs presented by the COVID-19 pandemic. The disposable nature of the device also accommodates stricter sanitization protocols amidst the pandemic. Around 80% of patients with COVID-19 exhibit neurological symptoms that could require EEG testing, the company noted.²

Additionally, the company’s data implied that only 30% of hospitals in the US have equipment for routine EEGs due to cost and space constraints. It referenced another study on the pandemic that found neurologic manifestations present at COVID-19 onset in 42.2% of patients at hospitalization and 62.7% at any time during the disease course in a cohort of 419 patients.³

Results also showed that the most frequent neurologic manifestations were myalgias (44.8%), headaches (37.7%), encephalopathy (31.8%), dizziness (29.7%), dysgeusia (15.9%) and anosmia (11.4%).

Brain Scientific also designed their NeuroEEG, which is a compact, portable and affordable wireless EEG device that fits in the palm of a patient’s hand. The 16-channel, FDA-cleared, clinical-grade device is intended for prescription use to acquire, record, transmit, and displace electrical brain activity for patients of all ages. NeuroEEG works in parallel with the NeuroCap device, taking less than 5 minutes to initiate the test and less than 25 minutes for the EEG test to be complete.⁴

REFERENCES

1. Brain Scientific announces FDA clearance for next-gen NeuroCap EEG headset. News release. Brain Scientific. March 9, 2021. Accessed March 9, 2021. http://www.globenewswire.com/news-release/2021/03/09/2189568/0/en/Brain-Scientific-Announces-FDA-Clearance-for-Next-Gen-NeuroCap-EEG-Headset.html

2. Brain Scientific seeks FDA Approval of next-gen NeuroCap™ EEG cap amidst new data on neurological problems in COVID Patients. News release. Brain Scientific. Published online October 13, 2020. Accessed March 9, 2021. https://www.globenewswire.com/news-release/2020/10/13/2107397/0/en/Brain-Scientific-Seeks-FDA-Approval-of-Next-Gen-NeuroCap-EEG-Cap-Amidst-New-Data-on-Neurological-Problems-in-COVID-Patients.html

3. Liotta EM, Batra A, Clark JR, et al. Frequent neurologic manifestations and encephalopathy associated morbidity in COVID-19 patients. Ann Clin Transl Neurol. Published online October 5, 2020. doi: 10.1002/acn3.51210.

4. NeuroEEG. Brain Scientific. https://www.brainscientific.com/neuroeeg/. Accessed March 9, 2021.