FDA OKs Brain Scientific’s Next-Gen NeuroCap EEG Headset

Brain Scientific Inc. has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-gen NeuroCap device, an advanced electroencephalogram (EEG) electrode array to obtain rapid EEGs in routine clinical and research settings.
 
“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 intensive care units and ERs,” Irina Nazarova, Marketing Director at Brain Scientific told the press.
 
NeuroCap is a disposable pre-gelled EEG headset with 22 electrodes and 19 active EEG channels located in accordance with the 10-20 system. Pre-gelled, fixed electrode locations eliminate time consuming tasks of head measurement and electrode placement. The cap is FDA-cleared to stay on a patient’s head for up to four hours. It’s compatible with most encephalographs on the market and can be applied in five minutes. 
 
Brain Scientific aims to boost neurological care access—the firm’s data implies only 30 percent of U.S. hospitals have routine EEG equipment because of cost and space constraints. Some studies show over 80 percent of hospitalized COVID-19 patients have neurological symptoms, which could require EEG testing. There’s also an urgent need to limit contact between EEG technicians and patients.