Neuralink Gets FDA Nod For Chip That'll Help Mute People Speak, Elon Musk Reacts

Blogs
Last Updated:
May 04, 2025

Neuralink, Elon Musk’s brain-chip company, has reached yet another significant milestone. A “Breakthrough Device Designation" has been granted by the US Food and Drug Administration (FDA) to the company for a new brain implant that will assist those who are unable to speak.

The declaration follows Neuralink’s announcement of the first successful human implantation of Blindsight, another technology designed to restore vision. This revolutionary communication chip is likely to go through human trials.

In a post on X (previously Twitter), Neuralink said that the FDA had authorised their latest brain chip, which will help those with severe speech difficulties communicate again. The chip has received the “Breakthrough Device Designation," a unique honour bestowed upon medical equipment that helps cure or diagnose illnesses that are life-threatening or permanently incapacitating.

“We’ve received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment," Neuralink said while sharing a thread.

https://x.com/neuralink/status/1918005257252098197

According to the company, this chip is intended for those with neurological issues, including multiple sclerosis, cerebral palsy, spinal cord injuries, stroke, ALS (amyotrophic lateral sclerosis), and others.

“This includes those affected by ALS, stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions," Neuralink claimed in another post.

All of these conditions impair speech and movement while allowing the brain to continue functioning normally.

https://x.com/neuralink/status/1918005259726729248

Neuralink has now asked people to register through its Patient Registry as it gets ready to begin human trials. “If you or someone you love has lost the ability to speak, you can sign up to our Patient Registry today and help shape the future of communication," the company said on X.

https://x.com/neuralink/status/1918005260875923758

As the posts were gaining traction, Elon Musk took to X and affirmed that Neuralink will make this technology broadly available, allowing anyone to access it in the future. “In the years to come, @Neuralink will make this technology widely available, so that ultimately anyone will have access to it," he proudly claimed.

Reportedly, Neuralink was already testing the technology before it received FDA certification. Bradford G Smith, a user who had lost his capacity to talk due to ALS, expressed his story on X.

https://x.com/ALScyborg/status/1916630186382291242

According to Smith, the brain chip replaced a part of his skull, and a robot injected its ultra-thin threads into his brain while avoiding blood vessels.