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Cognixion Receives FDA Breakthrough Device Designation for its Brain-Computer Interface with Augmented Reality for Assistive Communication

Friday, May 05, 2023

Cognixion, a renowned developer of noninvasive Brain-Computer Interface (BCI) and Augmented Reality (AR) technology, made an exciting announcement today. Their flagship device, the Cognixion ONE Axon, has been granted the prestigious Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). This designation will expedite the development and validation process, providing Cognixion with invaluable interactive feedback from FDA review staff to prepare for regulatory submission. The FDA awards this special designation to devices that show potential in treating life-threatening or irreversibly debilitating diseases or conditions where no clear alternatives exist.

The Cognixion ONE is a groundbreaking assisted reality device that combines AI, Augmented Reality, and Assistive Technology. It is specifically designed to assist individuals with severe motor impairments in communicating and interacting more effectively and independently with their surroundings. The device utilizes electroencephalogram (EEG) technology to create a noninvasive brain-computer interface (BCI), allowing patients in advanced disease stages to communicate their thoughts and mental attention through a wearable augmented reality headset. By integrating Artificial Intelligence (AI) technologies such as GPT large language models, the device can rapidly interpret the user's communication intentions and desired outcomes, providing suggestions that can be easily selected and conveyed audibly and visually through the front visor.

The primary focus of the Cognixion ONE is to aid individuals with neurodegenerative conditions like Amyotrophic Lateral Sclerosis (ALS) or Lou Gehrig's disease, Motor Neuron Disease (MND), as well as acquired conditions such as traumatic injuries and cerebral palsy that result in severe motor impairments. Currently, there is no approved device that allows fully paralyzed or locked-in patients to communicate once eye-tracking, the current standard of care, becomes unusable due to ocular motor decline.

Andreas Forsland, CEO and Founder of Cognixion, expressed their enthusiasm about receiving the FDA Breakthrough Device designation, considering it a significant milestone. Forsland emphasized the validation of their technology's potential to make a real difference in the lives of individuals with severe motor impairments. He also highlighted the importance of AI in assisting people in everyday situations. Cognixion remains dedicated to bringing this life-changing technology to those who need it most.

While several neurotech companies are developing invasive BCI technologies, such as Elon Musk's Neuralink, which aim to assist patients with communication abilities, Cognixion's device offers a unique advantage. It can be prescribed and utilized without the need for surgical procedures or extensive training, providing a new level of independence and autonomy to individuals who have struggled to communicate effectively due to their conditions. With further development, the Cognixion ONE has the potential to become a one-of-a-kind platform, incorporating additional inputs to restore lost abilities in language and personal agency for people facing such challenges.

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