The US Food and Drug Administration (FDA) has granted the Breakthrough Device Designation to Cognixion's Brain-Computer Interface (BCI) with Augmented Reality (AR) for assistive communication. Cognixion ONE is designed to help people with severe motor impairments communicate and interact more effectively and independently with the world around them. By using non-invasive technology to capture and interpret brain signals, the users can control a virtual keyboard or other computer interfaces with their thoughts. Due to the integrated AR component, the user experience is more intuitive and immersive. Additional Artificial Intelligence systems such as GPT large language models, support the user's communication. The combination of AR and AI allows the user a more natural communication and interaction. Preliminary testing has shown promising results. The US FDA Breakthrough Device designations are granted to expedite the review of technologies with the potential to greatly impact those suffering from life-threatening and debilitating diseases.