Neuralink, Elon Musk’s brain implant company, faces a new hurdle in its frank and wildly ambitious pursuit To treat blindness and paralysis. The Food and Drug Administration has dropped the Neuralink app to move forward with human trials using its device, according to the FDA. Thursday report From Reuters, credited to seven current and former FDA employees.
For years, Musk has repeatedly claimed human trials of him Brain computer interface Just around the corner. In 2019, Musk said his company was Obtaining US Food and Drug Administration (FDA) approval by the end of 2020. in 2021, The billionaire tweeted that his company might progress to human trials later the same year. In April 2022, Musk reportedly said Neuralink was seeking its first human transplant before 2023, according to Reuters. More recently, in November 2022, the CEO promised that human testing was only “about six months” away in disappointing condition. Show & Talk event at Neuralink. Now, it looks like the company will miss its self-imposed deadline as well.
Despite this history of allegations, Neuralink only filed its first application for FDA permission to conduct a proposed human trial in early 2022, and the agency denied the company’s request, according to Reuters. Gizmodo has reached out to the Food and Drug Administration to verify this claim and others, but the agency has not confirmed the Reuters account.
“We generally cannot confirm or deny the possible existence of a pending product application. To obtain this information, we suggest contacting the company,” FDA spokesperson Carly Kempler wrote to Gizmodo in an email. In response to specific questions about the Reuters report and Neuralink’s goal of human trials, Kempler also said, “We don’t have anything else to share at this time.”
Gizmodo reached out to Neuralink for further comment, but did not immediately receive a response. As with Musk’s other companies, such as Twitter And TeslaNeuralink rarely responds to inquiries from journalists.
However, it’s fair to say that the FDA’s rejection would be just another in the accumulating list of regulatory hurdles that Neuralink seems about to overcome. Musk’s biotech company has already been under federal investigation at least two times before Department of Agriculture and the US Department of Transportation over alleged animal welfare violations And Possible mishandling of hazardous biological materialsrespectively.
Why is the FDA refusing to apply Neuralink to human trials?
The US Food and Drug Administration gives the green light to about two out of three experimental human applications for medical devices in the first round, and about 85% in the second round, according to Reuters. So why didn’t Neuralink get approval?
Based on the accounts of several FDA workers, Reuters noted that the agency denied Neuralink’s application primarily because of “major safety concerns.” Obviously, the big sticking points included the lithium-ion battery for biotechnology devices, multiple small parts and wires that could end up dislodging or moving the brain, and the unresolved question of how to safely perform implant removal.
Neuralink has it I faced legal and public obstacles From the group advocating animal rights and anti-animal experimentation not least because of claims that its devices and practices are unsafe and inhumane – even for people tested on monkeys. The Physicians Committee for Responsible Medicine claims that hundreds of primates have endured needless (and horrific) suffering as a result of Neuralink’s experiments. In turn, Musk’s company has denied the PCRM allegations and defended its animal testing practices. “At Neuralink, we are fully committed to working with animals in the most humane and ethical way possible,” he wrote Statement 2022.
What does the FDA rejection mean for Neuralink?
If the rejection reports are accurate, that doesn’t mean Neuralink will never have its devices implanted in humans. It just means that the company will have to address the FDA’s concerns and try again.
However, despite Neuralink’s lofty aspirations to eradicate and create multiple human diseases Cyborg is able to survive the AI disasterThe company’s technology is not necessarily different or noticeable compared to competitors. Many companies and other organizations are researching brain-computer interface devices, which use electrodes to provide a communication channel between brain and computer signals.
At least one direct competitor, Synchron, has beaten Neuralink in human trials, and has received FDA approval to implant its device in a human. in 2021. company She said she had successfully implanted a BCI device in a person For the first time in July 2022. According to Previous Reuters report, Musk attempted to strike a deal between Neuralink and Synchron, after the latter’s historic achievement. Synchronicity didn’t seem interested.
.