FDA Rejected Human Trial for Elon Musk’s BCI Tech - Reuters

Elon Musk_Yichuan Cao/NurPhoto via Getty Images

Elon Musk/courtesy of Yichuan Cao/NurPhoto via Getty Images

In 2022, Elon Musk’s Neuralink tried – and failed – to secure permission from the FDA to run a human trial of its implantable brain-computer interface (BCI), according to a Reuters report published Thursday.

Citing seven current and former employees, speaking on the condition of anonymity, Reuters reported that the regulatory agency found “dozens of issues” with Neuralink’s application that the company must resolve before it can begin studying its tech in humans.

These include the risk of the device’s moving to other parts of the brain and safety of its lithium battery, the employees said. The FDA also wants to know whether Neuralink’s implant can be taken out without harming the brain.

In January 2022, Neuralink opened a position for a clinical trial director, a strong indicator that the company was looking to bring its implant into the clinic. This followed a December 2021 interview with The Wall Street Journal, where Musk said the company hoped to have its device in patients “by next year, depending on FDA approval.”

Musk has since had to adjust his timeline – and most likely will need to again.

Neuralink is currently trying to address the FDA’s concerns, according to the Reuters report, though three of the cited employees were “skeptical” that the company could do so quickly. A company document filed last fall noted that Neuralink was hoping the FDA would give its human trial the go-ahead by Mar. 7, 2023.

Musk’s company has not disclosed its regulatory application nor the FDA’s rejection to its investors. As a private company, Neuralink is not required to do so.

This is not the first time Neuralink has had trouble with federal agencies. In December 2022, Reuters reported that Department of Agriculture launched a probe of the company for alleged animal welfare violations.

Last month, Reuters also reported that the Department of Transportation was investigating Neuralink for allegedly transporting contaminated brain implants taken from the brains of research monkeys.

BioSpace has reached out to Neuralink and the FDA for comment.

Beaten to the Clinic

Neuralink’s product is a BCI device that, when implanted into the brain, will let recipients use their brains to control computers. The company is proposing to use its surgical robot to cut a coin-sized hole in the skull to deliver the implant and to stitch its tiny wires into the brain.

The tech, if proven safe and effective, could help restore function and independence to people with spinal cord injuries.

Another company working on a BCI implant is Synchron, whose main product-in-development, stentrode, could help severely paralyzed people control digital devices using their brains.

Synchron has beaten Neuralink to the clinic. In May 2022, the New York biotech kicked off its COMMAND study, which will evaluate the safety and explore the efficacy of stentrode. COMMAND is being funded by the National Institutes of Health and is being conducted under the first investigational device exemption awarded by the FDA.

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