Just a month after implanting its first Blindsight chip, Neuralink has announced that it has received the FDA’s Breakthrough Device Designation for its new brain chip aimed at helping individuals with severe speech impairments communicate. The designation, which is reserved for medical devices that offer transformative treatment for life-threatening or debilitating conditions, marks a major milestone for Elon Musk’s brain-tech company.
Neuralink shared the update on X (formerly Twitter), highlighting its progress toward restoring communication for those who cannot speak.
This includes those affected by ALS, stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions. (2/3)
— Neuralink (@neuralink) May 1, 2025
Neuralink’s recent FDA breakthrough designation marks a significant step toward restoring communication abilities for individuals suffering from conditions like ALS, stroke, spinal cord injuries, and other neurological disorders. The Elon Musk-led company announced that human trials for its new speech-restoring brain chip will begin soon and invited individuals affected by severe speech impairments to join its Patient Registry. Neuralink emphasized its goal of reshaping the future of communication for those who have lost the ability to speak, using advanced neural interface technology.
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The announcement follows promising early results, including a story shared by ALS patient Brad Smith, who regained his ability to communicate using Neuralink’s brain implant. The device, surgically embedded into his skull and brain with ultra-fine threads, detects neural signals through 1,024 electrodes and transmits them to a computer where AI decodes his intended actions.
Brad now navigates a cursor with his tongue and clicks by clenching his jaw—breakthrough abilities that highlight the implant’s life-changing potential. With FDA approval now in hand, Neuralink is poised to expand access to this revolutionary technology.
I am the 3rd person in the world to receive the @Neuralink brain implant.
1st with ALS. 1st Nonverbal.
I am typing this with my brain. It is my primary communication.
Ask me anything! I will answer at least all verified users!
Thank you @elonmusk! pic.twitter.com/bxYO3SBfA2
— Bradford G Smith (Brad) (@ALScyborg) April 27, 2025
Neuralink has reached a major milestone with the successful implantation of its experimental Blindsight chip into a human subject in 2025. Designed to restore vision in individuals who have lost both eyes and their optic nerves, the chip bypasses traditional pathways and stimulates the brain’s visual cortex directly. Elon Musk previously stated that the device could even allow people blind from birth to perceive visual input, provided their visual cortex is intact. This development could mark a revolutionary shift in how blindness is treated.
In addition to Blindsight, Neuralink continues to develop brain-chip interfaces aimed at helping individuals with paralysis. These devices, under the project name “Telepathy,” are designed to let users control digital devices using only their thoughts. The technology represents a broader push by Neuralink to build brain-computer interfaces that can restore lost functions and expand human capabilities through advanced neural engineering.
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