The US Food and Drug Administration (FDA) has granted a Breakthrough Device Designation to Cognixion’s brain-computer interface (BCI) integrated with augmented reality (AR) for assistive communication. This groundbreaking technology is aimed at enhancing the lives of individuals with communication disabilities, including those suffering from neurodegenerative diseases, spinal cord injuries, and other conditions.
Cognixion has been working to revolutionize the field of assistive technology by developing an innovative BCI-AR system. This state-of-the-art device can potentially provide an effective communication solution for individuals with limited mobility or speech impairments, allowing them to interact with the world around them more easily and autonomously.
The Breakthrough Device Designation from the FDA is granted to novel technologies that have the potential to provide significant advantages over existing options for diagnosing, treating, or managing life-threatening or irreversibly debilitating conditions. This status will expedite the regulatory review process, allowing the device to potentially reach the market more quickly and benefit patients sooner.
Cognixion’s BCI-AR system uses non-invasive technology to capture and interpret brain signals, enabling users to control a virtual keyboard or other computer interfaces with their thoughts. The integrated AR component provides an intuitive, immersive experience for the user, facilitating more natural communication and interaction.
The technology has undergone preliminary clinical testing, which has shown promising results in allowing individuals with limited mobility to communicate more effectively. Further research and development, as well as clinical trials, are necessary to refine and validate the technology’s safety and efficacy.
The FDA’s Breakthrough Device Designation for Cognixion’s BCI-AR system marks a significant milestone in the development of assistive technologies for individuals with communication disabilities. The potential impact of this innovative technology could improve the lives of millions of people, fostering greater independence and social interaction for those who struggle to communicate due to physical limitations.
The Cognixion One Headset
The company’s Cognixion ONE headset is where the BCI and AR are combined to provide a more intuitive and immersive communication experience for individuals with communication disabilities, such as those with neurodegenerative diseases, spinal cord injuries, or other conditions that limit mobility or speech.
The headset features high-definition displays, dry electrode EEG sensors, and advanced control systems like AI-driven signal processing, touch controls, eye tracking, and gesture controls. The Cognixion ONE operates on the Cognixion OS, which is built on the Android platform, and offers connectivity options like Wi-Fi and Bluetooth.
| Feature | Specification |
|---|---|
| Display | 1280×720 pixel high-definition resolution per eye with 16:9 aspect ratio, adjustable interpupillary distance |
| Sensors | EEG (electroencephalogram) dry electrode sensor array, 9-axis inertial measurement unit (IMU), Pupil tracking |
| Control System | BCI (Brain-Computer Interface) with AI-driven signal processing, Touch controls, Eye tracking, Gesture controls |
| Audio | Built-in stereo speakers, 3D spatial audio, Noise-cancellation microphones |
| Operating System | Cognixion OS, built on Android platform |
| Connectivity | Wi-Fi (2.4 GHz and 5 GHz), Bluetooth 5.0 |
| Battery | Up to 8 hours of continuous use |
| Comfort | Ergonomic design, Adjustable head straps, Lightweight and breathable materials, Comfortable face cushion |
| Compatibility | Compatible with Cognixion SpeakPRO app, Other popular communication apps, PC and Android applications |
| Language Support | Supports multiple languages, with more languages added regularly |
| Personalization | Customizable avatars, Environments, Visual and audio feedback settings |
| Accessibility | Access to Cognixion’s assistive technology platform for speech, language, and communication |
| Security and Privacy | Encrypted communication, Secure data storage, Compliant with privacy regulations (such as GDPR and HIPAA) |
| Support and Updates | Regular firmware updates, Customer support, Access to Cognixion ONE community and resources |
Equipped with an ergonomic design, adjustable head straps, and comfortable face cushion, the Cognixion ONE headset aims to improve communication, social interaction, and independence for individuals who struggle with physical limitations. It is compatible with Cognixion’s SpeakPRO app, other popular communication apps, as well as PC and Android applications, providing users with a versatile tool for assistive communication.
