Neuralink receives Breakthrough Device Designation from FDA, Elon Musk's sends congratulations to the team

Elon Musk ’s neurotechnology company, Neuralink has received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its speech restoration device . The company took to X to post about this achievement. “We've received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment,” posted the company on X. The company also claims that the device would help the people who are affected by amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions. Elon Musk also took to X to congratulate the Neuralink team for this achievement.


Neuralink’s new device a game-changer for speech restorationNeuralink revealed that its new device is designed to help people affected by ALS, stroke, spinal cord injuries, cerebral palsy, multiple sclerosis, and other neurological conditions. The company claims that the device will help them regain their ability to communicate. The company also claims that the implant works by identifying nueral signals and translate them into speech.

We've received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment. (1/3) pic.twitter.com/ou5hQoUtvp

— Neuralink (@neuralink) May 1, 2025

“If you or someone you love has lost the ability to speak, you can sign up to our Patient Registry today and help shape the future of communication,” posted the company on X.

If you or someone you love has lost the ability to speak, you can sign up to our Patient Registry today and help shape the future of communication. (3/3)https://t.co/jdKOJNhuKf

— Neuralink (@neuralink) May 1, 2025

What Elon Musk said about Neuralink’s achievement

Following the FDA’s announcement, Elon Musk took to X to congratulate the Neuralink team.The billionaire replied, “Congratulations, @Neuralink team!”

Congratulations, @Neuralink team! https://t.co/yfGlhUHEXk

— Elon Musk (@elonmusk) May 2, 2025

Elon Musk has long championed the development of brain-machine interfaces , envisioning a future where technology seamlessly integrates with human cognition.

The FDA's Breakthrough Device program is designed to expedite the review process for medical devices that offer the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.