Brain Scientific Announces FDA Clearance for Next-Gen NeuroCap™ EEG Headset

Rhea-AI Summary

Brain Scientific (BRSF) has received FDA 510(k) clearance for its next-generation NeuroCap™ device, designed for rapid EEGs in clinical settings. The new version features improved adhesion and an expanded size range, targeting broader applications beyond intensive care units and ERs. The NeuroCap™ is a disposable headset with 22 electrodes, compatible with most encephalographs, and can be applied within 5 minutes. With only 30% of U.S. hospitals equipped for routine EEGs, this innovation aims to enhance patient access to neurological care, particularly crucial during the ongoing pandemic.

Positive

• FDA clearance for NeuroCap™ enhances market credibility.
• Improved design features, including better adhesion and extended size range.
• NeuroCap™ reduces time to apply EEG monitoring to just 5 minutes.

Negative

• None.

NEW YORK, March 09, 2021 (GLOBE NEWSWIRE) -- via InvestorWire -- Brain Scientific Inc. (OTCQB: BRSF), a neurology-focused medical device and software company, announced today it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next generation NeuroCap™ device. NeuroCap™ is an advanced Electroencephalogram (EEG) electrode array used to obtain rapid EEGs in routine clinical and research settings where recording of STAT EEGs is desired.

“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,” said Irina Nazarova, Marketing Director at Brain Scientific.

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 4 hours. NeuroCap™ is compatible with most encephalographs on the market and can be applied in just 5 minutes. 

Brain Scientific wants to improve patient access to neurological care. The Company’s data implies that only 30% of U.S. hospitals have equipment for routine EEGs due to cost and space constraints. The global pandemic is still raging and some studies show that more than 80% of hospitalized COVID-19 patients have neurological symptoms, which could require EEG testing. Additionally, there is an urgent need to limit contact between EEG technicians and patients.

About Brain Scientific
Brain Scientific is a commercial-stage healthcare company with two FDA-cleared products, providing next-gen solutions to the neurology market. The Company’s smart diagnostic devices and sensors simplify administration, shorten scan time and cut costs, allowing clinicians to make rapid decisions and bridge the widening gap in access to neurological care.

To learn more about our corporate strategy, devices or for investor relations, please visit: www.brainscientific.com or email us at info@brainscientific.com

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements, which involve assumptions and describe our future plans, strategies and expectations, are generally identifiable by use of the words “may,” “should,” “would,” “will,” “could,” “scheduled,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “seek” or “project” or the negative of these words or other variations on these words or comparable terminology. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances, and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions, and are subject to several risks and uncertainties and other influences, many of which the Company has no control. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain additional financing, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the Company's inability to expand its business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, volatility in the price of the Company's raw materials and the Company's failure to implement the Company's business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC. The Company does not undertake to update these forward-looking statements.

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FAQ

What is the significance of the FDA clearance for Brain Scientific's NeuroCap™?

The FDA clearance allows Brain Scientific to market its NeuroCap™ device, enhancing its credibility and potential sales in the neurology market.

How does the NeuroCap™ improve EEG test administration?

NeuroCap™ streamlines EEG testing by using a pre-gelled headset that can be applied in just 5 minutes, eliminating the need for complex electrode placement.

What are the new features of the NeuroCap™?

The updated NeuroCap™ includes velcro strips for better adhesion and is now available in an extra small size for broader use across various patient profiles.

How does the NeuroCap™ address hospital shortages in EEG equipment?

With only 30% of U.S. hospitals equipped for routine EEGs, NeuroCap™ aims to improve access and efficiency, especially amid increased neurological symptoms in hospitalized COVID-19 patients.

What is the stock symbol for Brain Scientific?

The stock symbol for Brain Scientific is BRSF.