Cognixion has obtained breakthrough device designation from the US Food and Drug Administration (FDA) for its assisted reality device, Cognixion ONE Axon.

The newly granted status seeks to speed up the review of the device that could impact people suffering from life-threatening and devastating diseases.

Cognixion ONE intends to become the first FDA-approved device to help fully paralysed or locked-in patients communicate through a noninvasive brain-computer interface.

It is a brain-computer interface featuring augmented reality for assistive communication.

The device is capable of helping people with severe motor impairments communicate with other people more effectively and independently.

Leveraging electroencephalogram technology, it will offer a noninvasive brain-computer interface, thereby allowing patients with advanced disease progression to deliver their thoughts through a wearable, augmented reality headset.

Cognixion ONE integrates artificial intelligence (AI), such as GPT large language models, which run on the device with predictions related to the context.

The integration is expected to help the device quickly support the user’s communication intentions and anticipated outcomes.

It also offers suggestions that can be selected and communicated quickly both audibly and visually on the front visor as a communication assistance.

Cognixion ONE has been specifically developed to support individuals with various neurodegenerative conditions such as Amyotrophic Lateral Sclerosis or Lou Gehrig’s disease and Motor Neuron Disease.

It also aims to benefit people with acquired conditions such as traumatic injuries and cerebral palsy that lead to severe motor impairments.

Cognixion CEO and founder Andreas Forsland said: “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.”