Neuralink Receives FDA "Breakthrough" Designation for Speech-Enhancing Device

Last Updated May - 02 - 2025, 04:41 PM | Source : Fela News

Neuralink's device to help individuals with severe speech impairments, caused by conditions like ALS and stroke, has received FDA's "breakthrough" designation,

Neuralink, Elon Musk’s brain implant company, announced on Thursday that it has received the U.S. Food and Drug Administration's (FDA) "breakthrough" designation for its device aimed at restoring communication for individuals with severe speech impairments.

This device is designed to assist people with conditions such as amyotrophic lateral sclerosis (ALS), stroke, spinal cord injuries, cerebral palsy, multiple sclerosis, and other neurological disorders. The FDA's breakthrough devices program is designed to expedite the development, assessment, and review of medical devices, providing faster access to patients and healthcare providers. This designation helps accelerate the availability of innovative treatments to those in need. Both Neuralink and the FDA did not respond immediately to requests for further comment from Reuters.