Neuralink, Elon Musk's brain-chip company, has received significant progress with its latest FDA approval for its brain-chip technology. Just a month after the successful implantation of the Blindsight chip in a human, the FDA granted Neuralink “Breakthrough Device Designation” for a chip aimed at restoring communication for individuals with severe speech impairments. This designation is given to devices that promise to provide treatment for life-threatening conditions and has been awarded to Neuralink for its potential to assist those who have suffered from neurological conditions, such as ALS, stroke, spinal cord injuries, cerebral palsy, multiple sclerosis, and other conditions that affect speech.
Neuralink’s breakthrough technology aims to restore communication in people who have lost the ability to speak due to chronic illness. The company has announced that it will soon begin human trials for this speech-restoring chip and encourages individuals who have lost the ability to speak to sign up for the trials via its Patient Registry. This step marks a major milestone in the company’s goal to advance neurotechnology to improve the quality of life for individuals with severe physical impairments.
Neuralink’s Blindsight chip, an experimental implant designed to restore vision, was also recently implanted in its first human subject in 2025. The chip is particularly revolutionary because it offers the potential to restore vision in people who have lost both their eyes and optic nerves. It works by bypassing the eyes and directly stimulating the brain’s visual cortex, potentially offering sight to those who have been blind from birth or those who have lost their vision due to injury or disease, provided their visual cortex is intact. According to Musk, this chip could enable individuals to experience sight for the first time, regardless of their previous condition.
In addition to these advances, Neuralink is also working on developing brain-chip interfaces to assist individuals with paralysis. These interfaces would allow users to control digital devices purely through thought, a concept referred to as "Telepathy." The potential applications of this technology are vast, ranging from restoring independence to people with severe mobility impairments to enhancing human interaction with digital technology.
Brad Smith, an X user who was affected by ALS and lost the ability to speak, recently shared his experience with Neuralink’s technology. After receiving the implant, which consists of 1,024 electrodes, he regained the ability to communicate by moving a cursor on a computer screen with his tongue and clicking it by clenching his jaw. The implant, which was inserted by a robot with ultra-fine threads, detects neural activity and uses AI to decode his intended movements in real time. His progress demonstrates the transformative potential of Neuralink’s technology to help individuals regain lost abilities and communicate effectively, even after severe neurological damage.
Neuralink’s rapid developments reflect the company’s ambitious vision of pushing the boundaries of neurotechnology, offering the possibility of restoring sight, speech, and mobility to people who were previously left without hope. With the FDA’s approval and ongoing trials, Neuralink is advancing toward making these life-changing technologies available to the public, potentially reshaping the future of medical treatment for neurological conditions.
