Neuralink, Elon Musk’s startup, gets FDA nod for first human brain chip implant study.

Brandon DreyMay 26, 2023

Neuralink Receives FDA Approval for First In-Human Clinical Study

Elon Musk’s Neuralink neurotechnology startup company has received approval from the U.S. Food and Drug Administration (FDA) to launch its first in-human clinical study. This is a major milestone for the experimental brain-chip implant that could treat neurological disorders such as paralysis and blindness by bridging signals between existing neurons. The company has also claimed that it would allow humans to save and replay memories, saying that “the future is going to be weird.”

Neuralink received FDA breakthrough designation for its technology three years ago, and Musk repeatedly claimed that human trials would begin immediately. However, the company had its application rejected in early 2022 by the FDA over safety concerns. Seven current and former FDA employees told Reuters earlier this year that the agency’s major safety concerns involved “the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue.”

What’s Next for Neuralink?

Neuralink officials have said that the recruitment process for its clinical trial has not yet opened. The FDA has not issued a statement about the approval. Analysts from Grand View Research expect the worldwide market specific to brain implants to witness a compound annual growth rate above 9% over the next five years. The growing population of senior citizens, who are more likely to suffer from diseases such as Parkinson’s and Alzheimer’s, is expected to serve as a key market for the technology.

Other Advancements in Brain-Computer Interface Technology

News of the advancements in brain-computer interface technology comes as firms rush to develop artificial intelligence solutions. Paradromics, a company seeking to build direct data interfaces with the human brain, earned a breakthrough device designation last week from the FDA, granting the firm an expedited review process to incorporate the technology into medical applications. Earlier this month, researchers at the University of Texas in Austin unveiled a system that uses AI to transform a person’s brain activity into written words. The “semantic decoder” learns how to translate thoughts as the person listens to podcasts, and the system concurrently measures brain activity, then produces text that mirrors the meaning of the individual’s thoughts. The system does not require implants but is impractical for use outside of a laboratory.