Brain Scientific Announces CE Mark Approval for NeuroCap™ Device
Brain Scientific, a Florida-based medical device company, has received the Conformité Européenne (CE) Mark for its NeuroCap™, enabling the commercialization of its neurological devices in Europe. This approval confirms compliance with the European Medical Device Directive, addressing strong demand from European neurologists. NeuroCap™ simplifies EEG tests with its pre-gelled electrodes and can be utilized in various clinical environments. The company aims to increase market penetration in Europe, enhancing access to EEG testing for patients.
- Received CE Mark for NeuroCap™, allowing commercialization in Europe.
- Strong demand from European neurologists and distributors.
- Improves access to EEG testing in various clinical settings.
- None.
LAKEWOOD RANCH, Fla., Aug. 24, 2022 (GLOBE NEWSWIRE) -- via InvestorWire -- –– Brain Scientific (OTCQB:BRSF), a Florida-based medical device technology company, today announces receiving the Conformité Européenne (CE) Mark for the NeuroCap™. The CE mark confirms that Brain Scientific meets all European Medical Device Directive requirements to begin commercializing its innovative neurological devices across the European Continent and other CE mark geographies.
“The CE mark approval is yet another certification proving the effectiveness of Brain Scientific’s technologies,” said Daniel Cloutier, CEO of LOK Corporation. “We have seen strong demand from European neurologists and distributors for the NeuroCap™, and now with the CE mark Brain Scientific can start selling to medical facilities in Europe.”
“Our neurology products are accelerating access to EEG testing both in hospitals and in the field,” said Hassan Kotob, chairman and CEO of Brain Scientific. “The CE mark is a vital step forward as we increase our market penetration in Europe.”
Brain Scientific has developed two distinct devices to streamline EEG prep, testing, and diagnosis. NeuroCap™ has 22 pre-gelled electrodes making it a suitable option for most clinical EEG tests, including routine EEGs that are often used for stroke and epilepsy patients. The fixed electrode placement is in accordance with the international 10-20 system. NeuroEEG™ is a 21-channel amplifier that provides clinicians with the same quality as traditional EEG equipment.
The NeuroCap™ is an FDA 510k cleared, pre-gelled disposable EEG headset for clinical use. The NeuroCap™ allows any clinician to prepare a patient for an EEG exam in a fraction of the time normally spent applying individual electrodes. The NeuroCap™ can be used in nearly any environment, including rural hospitals, ambulances, private practices, and athletic events, vastly expanding access to EEG testing. It is currently available in four sizes, including pediatric sizes.
About Brain Scientific
Brain Scientific (brainscientific.com) is a medical technology company with multiple patents and FDA-cleared products. Brain Scientific is committed to developing next-gen solutions that advance the future of neurodiagnostic and OEM medical devices. Brain Scientific has two product lines covering neurology and precision motion. The NeuroCap™ and NeuroEEG™ are smart neurological diagnostic devices that simplify administration, shorten scan time, and cut costs. The Piezo Motion product line consists of ultra-efficient compact precision motors that will drive the next generation of medical devices. To learn more about Brain Scientific's corporate strategy, products, or investor relations, please visit 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 may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of EEG products and services and piezo motor technology; (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items; (iii) the company's future financial performance; (iv) the successful integration of Piezo Motion with and into Brain Scientific; and (v) the assumptions underlying or relating to any statement described in points (i), (ii), (iii) or (iv) above. 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 a number of risks and uncertainties and other influences, over 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 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 failure to implement the company's business plans or strategies. Some of 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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