Elon Musk gets FDA nod for human brain implant testing.

Neuralink Gets FDA Approval for Brain-Implant Clinical Trial

(Reuters)—Elon Musk’s brain-implant company Neuralink has received the green light from the U.S. Food and Drug Administration (FDA) for its first-in-human clinical trial, marking a significant milestone after facing earlier struggles to gain approval.

Neuralink announced the news on Thursday, stating that the FDA’s nod “represents an important first step that will one day allow our technology to help many people.” While the company did not provide further details on the study’s objectives, it did confirm that it is not yet recruiting participants and that more information will be available soon.

Elon Musk has long envisioned brain implants as a potential cure for a range of conditions, including obesity, autism, depression, and schizophrenia, as well as a means of enabling web browsing and telepathy. In fact, he made headlines last year when he expressed confidence in the devices’ safety and stated that he would be willing to implant them in his own children.

However, Neuralink has faced several setbacks in its efforts to bring its technology to market. The company had previously predicted that it would begin human trials on at least four occasions since 2019, but it only sought FDA approval in early 2022. In March, the agency rejected the application, citing concerns about the lithium battery, the possibility of the implant’s wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.

Neuralink Under Investigation

Neuralink, which was founded in 2016, has also been the subject of several federal probes. In May, U.S. lawmakers called for an investigation into whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments. Additionally, the Department of Transportation is investigating whether the company illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.

Finally, Neuralink is under investigation by the U.S. Department of Agriculture’s Office of Inspector General for potential animal-welfare violations. This probe is also examining the USDA’s oversight of Neuralink.

Despite these challenges, Neuralink’s FDA approval is a significant step forward for the company and for the field of brain-computer interfaces. We look forward to learning more about the clinical trial and the potential benefits of this groundbreaking technology.

• Key Takeaways:
• Neuralink has received FDA approval for its first-in-human clinical trial.
• The company has faced several setbacks in its efforts to bring its brain-implant technology to market.
• Neuralink is also under investigation by several federal agencies for potential violations.