Neuralink’s Speech Implant Stuns with FDA Breakthrough Win

In a seismic win for neurotechnology, Neuralink, founded by Elon Musk, revealed on May 1, 2025, that its speech restoration implant has clinched the FDA’s Breakthrough Device Designation. This coveted status, announced via a post on X, fast-tracks development for a device poised to restore communication for those with severe speech impairments caused by conditions like amyotrophic lateral sclerosis (ALS), stroke, spinal cord injuries, cerebral palsy, and multiple sclerosis. The implant decodes neural signals to enable speech, offering a lifeline to patients who’ve lost their voice. This milestone follows Neuralink’s 2024 breakthrough for its Blindsight vision implant and builds...