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Cognixion receives FDA Breakthrough Device Designation for assisted communication device

Cognixion receives FDA Breakthrough Device Designation for assisted communication device

Cognixion, a developer of non-invasive Brain-Computer Interface (BCI) and Augmented Reality (AR) technology, has announced that the US Food and Drug Administration (FDA) has granted its device Breakthrough Device Designation.

Cognixion One Axon is the bionic combination of AI, AR and assistive technology; an assisted reality device designed for people with severe neurodegenerative disorders such as amyotrophic lateral sclerosis (ALS) and motor neuron disease (MND), as well as developed conditions such as those after a traumatic injury or cerebral palsy. 

It allows them to communicate and interact effectively and independently by utilising electroencephalogram (EEG) technology within an augmented headset to provide BCI. At present, there are no cleared devices which allow locked-in or fully paralysed patients to communicate after ocular motor decline occurs, due to standard-of-care being based around eye-tracking.

Due to the headset utilising non-invasive BCI, Cognixion One Axon could be prescribed and used without the need for surgery or extensive training, providing more independence and autonomy for patients.

Andreas Forsland, CEO and founder of Cognixion, stated: “This FDA Breakthrough Device Designation is a significant milestone, and we are thrilled to receive it for our Cognixion ONE device. It 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. We are excited to continue our work to bring this life-changing technology to those who need it most.”

May 8, 2023


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