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Cognixion has developed a non-invasive BCI wearable platform integrating augmented reality and AI to enable communication for people with severe disabilities. The research version ("Axon-R") is available via Blackrock Neurotech's distribution network but not cleared by the FDA for therapeutic use. The clinical version ("Cognixion ONE Axon") has received FDA Breakthrough Device Designation. No published pivotal clinical trial results yet.
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