According to Musk, his brain implant business, Neuralink, would someday enable humans to transform into cyborgs and enable the blind and paralyzed to walk. But despite its seemingly modest objective of aiding disabled people in typing, the company still has trouble getting clinical trial permission.
Elon Musk Brain Chip
At least four occasions since 2019, Elon Musk has predicted that his medical device company, Neuralink, would soon start human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness.
Yet the company, founded in 2016, didn’t seek permission from the U.S. Food and Drug Administration (FDA) until early 2022 – and the agency rejected the application, seven current and former employees told Reuters.
The refusal has never before been made public. The officials said that in explaining the decision to Neuralink, the agency listed dozens of flaws that the business must resolve before human testing, a crucial step on the way to final product certification. According to the staff, the gadget’s lithium battery, the possibility that the implant’s small wires may spread to other parts of the brain, and the possibility that the device can be withdrawn without harming brain tissue were the agency’s main safety concerns.
FDA’s Rejection Of Elon’s Brain Chip
Neuralink is still working through the agency’s issues a year after the denial. Notwithstanding Musk‘s most recent promise that the firm would obtain FDA human-trial approval this spring at a presentation on Nov. 30, three employees said they were unconvinced the company could rapidly fix the obstacles.
The specifics of Neuralink’s trial application, the FDA’s rejection, or the scope of the agency’s concerns have not been made public. It is not necessary to report such regulatory interactions to investors as it is a private corporation. Musk said, without elaborating, that the business had submitted “most of our paperwork” to the FDA during the lengthy presentation in November, and Neuralink representatives acknowledged that the FDA had questioned the company’s safety during what they described as an ongoing conversation.
Musk or other Neuralink officials did not respond to requests for comment on the company’s device or its interactions with the FDA. Invoking laws that protect the confidentiality of business information, the government declined to comment on Neuralink.
The written denial from the agency, which is legally privileged information, was not made available to Reuters by the Neuralink sources. The staff members, under the condition of anonymity, described the safety concerns. Four of them had read the FDA letter, while others were aware of the agency’s worries.
According to Reuters, Such FDA denials do not necessarily indicate that a business will ultimately be denied the agency’s approval for human testing. More than a dozen specialists in the FDA device-approval procedures, however, believe that the agency’s opposition indicates serious issues.
Neuralink Working On Trial Permission
According to the experts, the company’s following requests for trial permission will be more challenging and at greater risk as a result of the refusal. According to the FDA, during the last three years, it has approved roughly two-thirds of all device submissions for human trials on the first try. After further assessment, that percentage increased to 85% of all requests. Yet, corporations sometimes give up after three efforts to address FDA concerns rather than spending more time and money on pricey research, according to a number of the experts.
Before submitting an application to the FDA for FDA clearance to commercially market a device, businesses that successfully obtain human testing approval normally undertake at least two rounds of studies.
According to more than a dozen current and former workers of the firm, Neuralink’s regulatory issues are largely the result of its culture of setting targets for breakthroughs on incredibly aggressive deadlines and considering regulators as barriers to innovation. The employees claim that Musk’s management approach, which is similar to how he oversees electric vehicle pioneer Tesla, can lead to weaknesses that can help manufacture medical devices to help test on human subjects before approval.
Yet, Musk continues to enjoy the full support of many devoted Neuralink employees and some business investors, who highlight his prior achievements in taking on difficult challenges as the inventor of Tesla and rocket manufacturer SpaceX.
Bob Nelsen’s Comment On The Brain Chip
“I definitely would never bet against him,” said Bob Nelsen, co-founder of venture capital firm ARCH Venture Partners, who said he invested personal money into Neuralink. “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.”
Throughout the years, Musk has outlined a daring vision for Neuralink in public comments: Both healthy and disabled individuals will visit nearby institutions for quick surgical implantations of gadgets that can do everything from treat obesity, autism, depression, or schizophrenia to allow online browsing and telepathy. According to Musk, these chips would eventually transform people into cyborgs capable of fending off the threat posed by sentient robots equipped with artificial intelligence.
Elon’s Comment On The Brain hip
At the livestreamed “show and tell” session on Nov. 30, Musk said, “I could have a Neuralink device inserted right now, and you wouldn’t even know,” to laughter from the audience. He stated: “You’ll be able to keep and revisit experiences… at another public company event in 2020. The future will be strange.
Four people with knowledge of the private appraisal attribute Neuralink’s predicted worth of more than $1 billion, which is far more than that of its competitors, to such an ambitious goal.
Neuralink officials have publicly vowed to address any FDA concerns. Musk made headlines late last year when he said he was already so confident in the devices’ safety that he would be willing to implant them in his own children.
Officials from Neuralink have openly committed to allay any FDA worries. Musk gained notoriety late last year when he declared that he would be willing to have his own children fitted with the devices due to his level of confidence in their safety.
NIH’s Comment On Elon’s Brain Chip
According to Kip Ludwig, a former program director for neural engineering at the U.S. National Institutes of Health (NIH), a federal organization, Musk’s public assertions and well-known impatience present a crucial test for the FDA in juggling demands for a quick review with the care needed to ensure safety and efficacy. Congress has recently put pressure on the FDA to expedite reviews, but the agency has also come under fire for debatable decisions like the 2021 clearance of a medication for Alzheimer’s without conclusive evidence of efficacy.
Ludwig stated that because the billionaire is pressuring Neuralink to move through regulatory evaluations fast, industry players who are actively following Neuralink’s progress have long anticipated a collision between Musk and the FDA.
Ludwig said of Musk’s application for FDA approval the brain chip: “Everyone in the industry was saying: ‘Oh my God, they’re going to run straight into a brick wall. Neurolink doesn’t seem to have the perspective or background necessary to bring this product to market anytime soon.
The FDA stated it upholds rigorous standards in assessing all brain implants even as it attempts to speed up evaluations without making any mention of Neuralink. The FDA’s Office of Product Evaluation and Quality is under the direction of Owen Faris, who asserts that innovation and safety are not mutually exclusive.