Neuralink's speech restoration device gets FDA's 'breakthrough' tag

The Neuralink 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.