Cognixion has received the US Food and Drug Administration (FDA) Breakthrough Device designation for its brain-computer interface (BCI) technology, Cognixion ONE Axon.

Cognixion ONE Axon is an advanced assisted reality device that leverages bionic combination or AI, augmented reality and assistive technology.

It enables people suffering from severe motor impairments to communicate and interact more effectively and independently with the world around them.

The device uses electroencephalogram (EEG) technology to provide a non-invasive BCI that enables patients to communicate responses through a wearable, augmented reality headset.

With the current Breakthrough Device designation, Cognixion aims to advance the development and validation of Cognixion ONE, with support from FDA, and prepare for regulatory submission.

Cognixion founder and CEO 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.”

Cognixion ONE Axon has been specifically designed to help individuals with neurodegenerative conditions, eliminating the need for surgical procedures or significant training.

The conditions include Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig’s disease and Motor Neuron Disease (MND), along with acquired conditions such as injuries and cerebral palsy.

The device integrates AI, such as GPT large language models, with contextual predictions to rapidly support the communication intention of the user and desired outcomes.

It serves as a communication aid, providing suggestions that can be rapidly selected and communicated audibly and visually on the front visor.

The company said that it plans to further develop Cognixion ONE Axon by gathering additional inputs to restore advanced abilities that have been lost to people with loss of language.