Elon Musk’s Neuralink Startup Receives FDA Approval For First In-Human Brain Chip Implant Clinical Study

Elon Musk’s Neuralink neurotechnology startup company received approval from the U.S. Food and Drug Administration (FDA) on Thursday to launch its first in-human clinical study.

“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” the company said on Twitter.

Musk has touted that over the years, the experimental brain-chip implant could treat neurological disorders such as paralysis and blindness by bridging signals between existing neurons, and would allow humans to save and replay memories, saying that “the future is going to be weird.”

Neuralink received FDA breakthrough designation for its technology three years ago, and Musk repeatedly claimed that human trials would begin immediately. However, the company had its application rejected in early 2022 by the FDA over safety concerns.

Seven current and former FDA employees told Reuters earlier this year that the agency’s major safety concerns involved “the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue.”

“We want to be extremely careful and certain that it will work well before putting a device into a human,” Musk said, according to Reuters. “The progress at first, particularly as it applies to humans, will seem perhaps agonizingly slow, but we are doing all of the things to bring it to scale in parallel. So, in theory, progress should be exponential.”

The approval comes as U.S. lawmakers requested that regulators investigate how the company has conducted animal testing and if those trials were rushed or resulted in failed experiments.

Neuralink has also faced other federal investigations, including from the USDA’s Inspector General over concerns of violating the Animal Welfare Act and the U.S. Department of Transportation over accusations over the movement of hazardous pathogens.

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Neuralink officials said the recruitment process for its clinical trial has not yet opened.

The FDA has not issued a statement about the approval.

Analysts from Grand View Research expect the worldwide market specific to brain implants to witness a compound annual growth rate above 9% over the next five years. The growing population of senior citizens, who are more likely to suffer from diseases such as Parkinson’s and Alzheimer’s, is expected to serve as a key market for the technology.

Deep brain stimulators, which send electrical impulses through electrodes implanted in the brain, currently occupy the largest market share in the broader brain implant space. Increased awareness of the treatment options for neurological movement disorders is expected to accelerate growth in the sector.

Vagus nerve stimulators, which send impulses to the brain through the vagus nerve, are expected to grow at the fastest annualized rate.

News of the advancements in brain-computer interface technology comes as firms rush to develop artificial intelligence solutions.

Paradromics, a company seeking to build direct data interfaces with the human brain, earned a breakthrough device designation last week from the FDA, granting the firm an expedited review process to incorporate the technology into medical applications. The company is seeking to develop an implanted brain-computer interface, also called a BCI, that can function outside of a laboratory to assist patients who lose the physical ability to speak or type, such as those impacted by spinal cord injuries and strokes.

Earlier this month, researchers at the University of Texas in Austin unveiled a system that uses AI to transform a person’s brain activity into written words. The “semantic decoder” learns how to translate thoughts as the person listens to podcasts, and the system concurrently measures brain activity, then produces text that mirrors the meaning of the individual’s thoughts. The system does not require implants but is impractical for use outside of a laboratory.

Ben Zeisloft contributed to this report.

DeSantis Hauls In Whopping $8.2M In First 24 Hours As Presidential Candidate

Florida Governor Ron DeSantis raised a whopping $8.2 million in his first 24 hours of fundraising as a presidential candidate.

The New York Times reported that the $8.2 figure was more than a $6.3 million that President Joe Biden raised in the first 24 hours of his campaign. It is believed to surpass the amount raised by former President Donald Trump after his 2024 announcement last November, although Trump did not release fundraising totals after the first 24 hours of his 2024 campaign.

Given that Trump’s campaign reported having raised $9.5 million during its first six weeks, DeSantis’ haul “far outpaces” how Trump “began his 2024 fund-raising in late 2022.”

The $8.2 million are hard dollars that the campaign can use, the report added.

“This historic fundraising haul shows that grassroots Republicans across the country are uniting behind Governor DeSantis’ vision for our Great American Comeback,” campaign manager Generra Peck said. “Governor DeSantis has built the strongest, most sophisticated organization in the history of American politics, and the tremendous support we’ve experienced in the last 24 hours will be critical as we hit the ground running in the early nominating states to share Governor DeSantis’ plan to revitalize the American Spirit.”

Never Back Down, a pro-DeSantis super PAC, says that it has already raised $40 million in its first two months of operation and it expects to get an $86 million infusion from DeSantis’ state pac that he used to raise funds as governor. DeSantis severed his connection with the pac, Friends of Ron DeSantis, a couple of weeks ago, which should allow the money to be transferred to Never Back Down.

A separate report from the Times said that Never Back Down is preparing to have a $200+ million budget, half of which it is going to use to fund a “voter-outreach push so big it plans to knock on the door of every possible DeSantis voter at least four times in New Hampshire, Nevada and South Carolina — and five times in the kickoff Iowa caucuses.”

The ground operation plans to hire nearly 3,000 field organizers by Labor Day, which the Times noted was “an extraordinary number of people for even the best-funded campaigns.”

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“No one has ever contemplated the scale of this organization or operation, let alone done it,” said Chris Jankowski, the group’s chief executive. “This has just never even been dreamed up.”

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