Thursday, August 25, 2022
Brain Scientific, a Florida-based medical device technology company, has announced that it has obtained the Conformité Européenne (CE) Mark for its NeuroCap™. This certification confirms that Brain Scientific complies with all the requirements of the European Medical Device Directive, allowing the company to commence commercialization of its innovative neurological devices in Europe and other CE mark geographies.
Daniel Cloutier, CEO of LOK Corporation, expressed his satisfaction with the CE mark approval, stating, "The CE mark approval is yet another certification proving the effectiveness of Brain Scientific's technologies. We have witnessed strong demand from European neurologists and distributors for the NeuroCap™, and now, with the CE mark, Brain Scientific can initiate sales to medical facilities in Europe."
Hassan Kotob, chairman and CEO of Brain Scientific, emphasized the significance of the CE mark as a crucial step forward in expanding their market presence in Europe. He said, "Our neurology products are accelerating access to EEG testing both in hospitals and in the field."
Brain Scientific has developed two distinct devices that streamline EEG prep, testing, and diagnosis. The NeuroCap™ features 22 pre-gelled electrodes, making it suitable for most clinical EEG tests, including routine EEGs frequently conducted for stroke and epilepsy patients. The fixed electrode placement adheres to the international 10-20 system. On the other hand, the NeuroEEG™ is a 21-channel amplifier that offers clinicians the same quality as traditional EEG equipment.
The NeuroCap™, which is already FDA 510k cleared for clinical use, is a disposable EEG headset with pre-gelled electrodes. It enables any clinician to prepare a patient for an EEG exam in a fraction of the time typically required for applying individual electrodes. The NeuroCap™ can be utilized in various settings, including rural hospitals, ambulances, private practices, and athletic events, significantly expanding access to EEG testing. Currently, it is available in four sizes, including pediatric sizes.
