Regulators reject Musk’s brain chip

OAN Roy Francis
7:31 AM PT – Friday, March 3, 2023

The United States Food and Drug Administration has rejected Elon Musk’s proposal for Neuralink, which would have allowed human trials to be conducted with the brain chip.

According to Reuters on Thursday, current and former employees said that the FDA rejected their application in the early 2022. While the company was founded in 2016, it was not the first time that the FDA had received a proposal for a human trial chip.

Musk predicted that in 2019, his company would conduct human trials of its revolutionary brain implant. Neuralink’s implant will treat intractable conditions. This would include blindness and paralysis.

Although the rejection was not reported previously, staff say that Neuralink had already reported many issues that Neuralink needed to address before it could be approved for human trials. The company was primarily concerned about the use of the lithium-ion battery in the chip. FDA expressed concern about the possibility of implant wires moving to other parts of the brain. They also asked how the chip could be removed from the brain without causing any damage.

Musk last stated that his company would be approved to proceed by spring. The company’s staff is still working on safety concerns raised by FDA and it is doubtful that they will be able address them by that deadline.

This rejection was a huge setback for the company, since the FDA had previously approved almost two-thirds (or more) of all human trials applications. After the second request, the approval rate rose to 85%.

Musk has the full trust of his staff and investors in the industry, but he is still confident because of his success with extreme challenges.

Bob Nelson, co-founder of ARCH Venture Partners has made personal investments in Neuralink but is confident in Musk’s ability and drive.

“I definitely would never bet against him,” He stated. “If he has some bumps in the road with Neuralink, or any other thing, he’ll regroup and figure it out. Just think about it: Those are hard industries with huge safety barriers – cars and rockets.”

Musk had an extremely strong vision for his company’s future. Musk presented his vision to the public, stating that disabled and healthy individuals will be able visit facilities to insert the chips quickly. The chips will be available for use in the following locations: “cure” Depression, obesity, schizophrenia, and other conditions would allow for web-surfing or telepathy.

Musk’s ambitious goals have boosted the company to over $1Billion. But, the company’s top staff has smaller goals for the near term. Dongjin Seo is Neuralink’s vice President of Engineering. He stated that the immediate goal for the company is “to help paralyzed patients communicate through computerized text without typing.” Musk’s goals, he stated, are his. “long-term” goals.

Its insistence on speed has led to problems. Reuters also reported 2022 that federal agencies were investigating the treatment of research animals by the company.

The U.S. Department of Agriculture’s Office of Inspector General is currently investigating claims that the company had caused additional suffering or death of monkeys, sheep, and pigs during trials. The Department of Transportation also investigated whether dangerous pathogens were illegally transported by the company on chips taken from monkey brains without proper containment.

Neuralink is facing stiff competition in its industry. Blackrock Neurotech and Medtronic are other companies that compete in the implant market. Some of these companies have had products on the market for many years, while others have received human trials approvals. Precision Neuroscience is another competitor facing Neuralink. Precision Neuroscience was co-founded by Benjamin Rapoport in 2021.

Neuralink’s goals are ambitious and the owner’s past successes and breakthroughs in areas previously deemed unrealistic have raised expectations.