FDA Certification

NeuroSky is, by and large, a technology provider (think of Intel). Our mission is to furnish a broad set of application developers (from toys and games to safety, wellness, education and medical) with a straightforward, mobile and affordable platform on which to develop applications. Our current offerings are not FDA certified as it would add time and cost to an equation that does not tolerate either well. We do not, ourselves, design medical equipment, it is not our goal.

Having said that we do work with numerous developers that are, in fact, developing for the medical community. These projects range from treatment for ADHD to diagnostic/treatment systems for cognitive disorders. To support our partners in the medical community we furnish components manufactured to the ISO 13485 spec. This allows our partner to design their medical solution in a way that it is ready for them to bring it through the FDA and other medical certifications.