Neuralink’s speech restoration device gets FDA’s ‘breakthrough’ tag
Neuralink has received the U.S. Food and Drug Administration’s “breakthrough” tag for its device to restore communication for individuals with severe speech impairment, Elon Musk’s brain implant company said on Thursday in a post on X.
The device would help those affected by amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions, the company said.
The health regulator’s breakthrough devices program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review, according to its website.
The FDA and Neuralink did not immediately respond to Reuters requests for comment.
