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Cognixion won FDA breakthrough designation this year for its noninvasive Cognixion One Axon brain-computer interface augmented reality device.
The wireless device is designed to facilitate communication and interaction for severe motor impairment patients who can’t use eye-tracking technology due to ocular motor decline.
Breakthrough device designation means the FDA sees big potential in the system and will allow Cognixion to accelerate its next regulatory submission.
The breakthrough designation “validates the potential of our technology to make a real difference in the lives of individuals with severe motor impairments and underscores the importance of how AI can be used to assist people in everyday situations,” Cognixion founder and CEO Andreas Forsland said.