Neuralink's Revolutionary Speech Restoration Device Earns FDA Breakthrough Status

- Neuralink, Elon Musk’s brain implant firm, announced on Thursday via an X post that the U.S. Food and Drug Administration had granted its device a “breakthrough” designation aimed at restoring communication abilities for people severely impaired in their speaking capabilities.

The gadget would assist individuals impacted by ALS, stroke, spinal cord injuries, cerebral palsy, multiple sclerosis, and various other neurological disorders, according to the firm.

According to its website, the health regulator’s breakthrough devices program aims to offer patients and healthcare providers quicker access to medical devices by expediting their development, evaluation, and review processes.

The FDA and Neuralink did not promptly reply to requests for comment made via https://smarthealthradar2025.blogspot.com/.

(Sriparha Roy reported from Bangalore; Edited by Krishna Chandra Eluri and Shailesh Kuber)