Brain-computer interfaces are one of the most ambitious new frontiers in technology. And now, Neuralink is aiming to use them to solve speech impairments.
What’s happening:
- Elon Musk’s Neuralink has received a Breakthrough Device designation from the United States Food and Drug Administration for their brain-computer interface aiming to restore speech in individuals who have severe speech impairments
Why it matters:
- This is one of the very few Breakthrough Device designations that the United States Food and Drug Administration has ever given to a private company focused on speech impairment
Going deeper:
- The new Breakthrough Device designation will enable Neuralink to collaborate closely with the United States Food and Drug Administration on designing their technology as well as expediting the regulatory pathway and clinical trial process
- Neuralink has now successfully implanted their brain-computer interface chip into several human patients and is currently in the process of recruiting patients who have severe speech impairments for a clinical trial to further validate their brain-computer interface
The intrigue:
- This is also not the first time that Neuralink has earned a Breakthrough Device designation, previously being awarded one for their Blindsight medical device which is focused on restoring vision in individuals who are blind or significantly visually impaired
