Neuralink to Begin Human Trials on Speech Device

Neuralink has received the FDA's Breakthrough Device Designation for its brain implant designed to restore communication in people with severe speech impairments caused by neurological conditions such as ALS, stroke, spinal cord injury, cerebral palsy, and multiple sclerosis. The designation is intended to accelerate regulatory review, allowing faster development and assessment of the device. Human trials are set to begin soon, with Neuralink inviting patients to join its registry. The implant detects neural activity and uses AI to decode intended speech or cursor movements, as shown in a demonstration where an ALS patient regained communication abilities. Elon Musk publicly congratulated the Neuralink team on this milestone, highlighting the company's progress toward advanced human-technology integration. This recognition marks a significant advance in assistive technology for those with debilitating neurological disorders.