The FDA is denying Neuralink’s application to begin human trials

Try as he may, Elon Musk seems unable to deliver on Neuralink’s lofty goals and promises. Since 2019, Musk has repeatedly claimed that his brain-computer interface (BCI) technology company is on track to begin human trials immediately. However, a new one Reuters Research has revealed that the company applied for clinical trial approval from the Food and Drug Administration just last year, only to be turned down over multiple safety concerns.

[Related: Elon Musk hopes humans will be testing Neuralink brain implants in the next six months.]

Reuters reports that current and former Neuralink employees describe dozens of FDA concerns that need to be addressed before the company’s human clinical trials can even begin. In particular, sources say the agency has reported safety issues related to remote charging of the device’s lithium batteries and has requested animal test data that suggests the power source would be “very unlikely”. Speak with ReutersBrain implant experts explained that if part of the device connected to a battery source fails, the current could severely injure brain tissue.

In addition, regulators have raised concerns about the possibility of Neuralink implant wires inadvertently migrating to other regions of the brain, thereby increasing the likelihood of inflammation, ruptured blood vessels and impaired brain function. The FDA also reportedly wants more evidence that the devices don’t overheat and can be safely removed without damaging patients’ delicate brain tissue.

[Related: Elon Musk’s Twitter suspends journalists.]

During Neuralink’s “Show and Tell” presentation in November 2022, Musk publicly stated that “most of our paperwork” had been submitted to the FDA for approval of human trials, though he didn’t provide details on the process. Because Neuralink is a private company, it is not legally required to disclose to investors its communications with regulatory agencies such as the FDA. For this reason, Reuters explains that many precise details about its barriers to human testing remain unclear, since neither Neuralink nor Musk have responded to requests for comment.

Similar to his other ventures, Musk frequently has sky-high — if often ambiguous — expectations of Neuralink. During last year’s show-and-tell presentation, he reiterated his goal of developing a line of upgradeable computer brain implants that could eventually treat medical conditions like paralysis, blindness and hearing loss, as well as provide means for supposedly telepathic communication and online access. At the time, Musk estimated that human trials could begin within the next six months.

Musk’s roadmap has taken several detours in recent months, most notably in a series of controversial reports alleging ethical issues surrounding Neuralink’s animal testing. Last year, the multi-company CEO confirmed that a number of monkeys died as a result of BCI testing, prompting swift reprimands from activists and medical professionals.

[Related: Brain interfaces aren’t nearly as easy as Elon Musk makes them seem.]

Amidst muted expectations regarding Neuralink’s BCI advances, experts from a variety of fields have repeatedly called for caution, reminding consumers that the technology is far more complicated than Musk might be suggesting. The FDA’s recent rejection of human trials doesn’t mean that Neuralink will never reach that stage of development, but it does dampen expectations as to when the public will actually see such advances. Meanwhile, competitors like Synchron — backed by Bill Gates and Jeff Bezos — are already conducting their own human clinical trials for similar brain-computer implants.

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