Neuralink's speech-restoring chip gets Breakthrough Designation from FDA

The company said that its applications can be extended to individuals affected by ALS, stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions

Elon Musk’s 'brain-chip' company Neuralink on Thursday announced that its chip that helps in speech restoration has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).

 

In a post on X, the company said, "We've received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment."

 

The company added that this includes individuals affected by ALS, stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions. It also invited those who have lost the ability to speak to sign up for its patient registry.

 

We've received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment. (1/3) pic.twitter.com/ou5hQoUtvp

— Neuralink (@neuralink) May 1, 2025

 

 

What does the Breakthrough Device Designation mean?

 

The FDA's Breakthrough Devices Program is designed to expedite the development and review of medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions.

 

"is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review...," according to FDA's website.

 

ALS patient shares experience with Neuralink

The announcement follows a post by X user Bradford G Smith, who said that Neuralink's implant had helped him communicate again after ALS robbed him of his ability to speak.

 

He explained that the device contains 1,024 electrodes that detect neural activity. These signals are transmitted to a computer, where artificial intelligence decodes his intended movements in real time, thus allowing him to operate a cursor.

 

Neuralink had reshared his post ahead of its official announcement.