Neuralink device gets FDA recognition for speech restoration

Neuralink’s brain-computer interface (BCI) device, Link, has secured the U.S. Food and Drug Administration’s (FDA) “breakthrough” designation for restoring communication in patients with severe speech impairment. This milestone advances Elon Musk’s vision of merging human cognition with technology.

The Link device targets individuals with neurological conditions like Amyotrophic Lateral Sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, and multiple sclerosis. In a recent X video, Neuralink’s third PRIME Study participant, Bradford G. Smith, who lives with ALS, showcased the device’s potential.

Using Link, Smith regained his ability to communicate, leveraging AI to narrate with a synthesized version of his former voice. “I am typing this with my brain,” Smith wrote. “It is my primary communication.”

Smith edited the X video with the help of Link. In the video, he demonstrated how Link enabled him to control a computer cursor to communicate, highlighting the BCI’s ability to interface with external devices.

Before Link, Smith relied on an eye tracker, which limited communication in bright settings and restricted his mobility. Now, Neuralink’s implant enables him to connect more freely. His experience shows Neuralink’s progress in empowering paralyzed individuals and those with neurodegenerative diseases through revolutionary assistive solutions.

The company is also exploring applications for vision restoration and other health challenges. In 2024, Neuralink received the FDA’s ‘breakthrough device’ tag for its Blindsight device. Elon Musk explained that Blindsight would help people who have lost both eyes and function in their optic nerve to see. However, Neuralink’s current focus remains on mobility and communication.

Neuralink recently expanded its patient registry to include participants worldwide. The PRIME Study, likely the primary target for new registrants, tests Link’s base capabilities. Meanwhile, the CONVOY study explores Link’s ability to control robotic devices, like an assistive robotic arm. This broader access underscores Neuralink’s commitment to scaling its trials.

The company is reportedly preparing for a $500 million funding round, with preliminary talks valuing Neuralink at $8.5 billion pre-money and potentially $9 billion post-money, though terms remain fluid. Neuralink has not commented on the speculation about funding.

By earning FDA breakthrough status, Neuralink positions Link as a transformative tool for those with severe speech impairments. Smith’s experience illustrates its potential to restore independence, while ongoing trials and funding efforts signal the company’s ambition to redefine human-technology interaction for neurological conditions and beyond.

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