Neuralink wins FDA breakthrough nod for treating speech impairment

Neuralink said today on social media that it received FDA breakthrough device designation for treating individuals with severe speech impairment.

This breakthrough nod extends to a number of neurological conditions, according to a LinkedIn post made by the Elon Musk-backed brain-computer interface (BCI) maker.

“We’ve received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment,” Neuralink wrote from its official account. “This includes those affected by ALS, stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions.”

This breakthrough nod marks the latest milestone for the BCI company. It completed the first human implant of its Telepathy BCI implant in January 2024 and later completed a second implant last year. A nine-minute livestream demonstration showed Noland Arbaugh using the Neuralink BCI to move a computer cursor and play chess online.

Sign up for Blog Updates