Cognixion receives FDA Breakthrough Device Designation for assisted communication device

Title: Empowering Communication: Cognixion’s FDA Breakthrough Device Designation


Communication is at the core of human interaction, and for individuals with speech disabilities, assisted communication devices play a vital role in enabling them to express themselves. Cognixion, a pioneering assistive technology company, has recently received the prestigious FDA Breakthrough Device Designation for their innovative assisted communication device. In this blog, we will explore the significance of Cognixion’s achievement and highlight key points that make their device a game-changer in the field of assistive communication.

Key Points:

  1. Breaking Barriers with FDA Breakthrough Designation:

The FDA Breakthrough Device Designation is a recognition granted to transformative medical devices that address unmet medical needs or provide significant advantages over existing alternatives. Cognixion’s assisted communication device receiving this designation underscores its potential to revolutionize the field and improve the lives of individuals with speech disabilities. This designation provides accelerated access to the device for patients, helping them communicate more effectively and efficiently.

  1. Advanced Brain-Computer Interface Technology:

Cognixion’s assisted communication device utilizes advanced brain-computer interface (BCI) technology. By integrating wearable electroencephalogram (EEG) electrodes, the device can interpret brain signals and convert them into personalized communication output. This breakthrough technology empowers individuals with speech disabilities to express their thoughts, ideas, and needs through real-time communication, bridging the gap between their internal world and the external environment.

  1. Enhanced User Experience and Accessibility:

One of the key strengths of Cognixion’s device lies in its focus on user experience and accessibility. The device’s intuitive user interface and customizable features cater to individuals with diverse communication needs and abilities. Through machine learning algorithms, the device adapts to the user’s unique linguistic patterns, gestures, and preferences, enhancing the communication accuracy and speed over time. Furthermore, the device is designed to be portable and compatible with various assistive technologies, ensuring seamless integration into the user’s daily life.

  1. Promoting Independence and Empowerment:

Cognixion’s assisted communication device goes beyond just facilitating communication; it empowers individuals by promoting independence and social participation. By enabling individuals with speech disabilities to express themselves more efficiently and effortlessly, the device helps break down communication barriers and fosters a sense of agency. This newfound independence can significantly enhance someone’s quality of life, allowing them to participate more fully in social interactions, education, professional environments, and personal relationships.

  1. Potential for Future Advancements:

The FDA Breakthrough Device Designation not only highlights the current impact of Cognixion’s device but also paves the way for future advancements in the field of assisted communication. As the device continues to evolve and benefit from ongoing research and development, it has the potential to unlock even more capabilities. This designation encourages further investment, collaboration, and innovation in the field and sets a precedent for other assistive communication technologies seeking similar recognition.


Cognixion’s FDA Breakthrough Device Designation for their assisted communication device marks a significant milestone in the field of assistive technology. By harnessing the power of advanced brain-computer interface technology, Cognixion empowers individuals with speech disabilities to communicate effectively, promoting independence and social inclusion. The recognition from the FDA not only represents the current impact of the device but also promises future advancements and breakthroughs in the field. With Cognixion’s innovative device, the barriers to communication are being shattered, giving a voice and a platform to those who were previously unheard.