Elon Musk’s Neuralink recently announced that the FDA in the country had approved the launch of its first-ever human clinical study. The official Twitter account of the company posted, “We are excited to share that we have received the FDA’s approval to launch our 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.” Currently, the company hasn’t recruited any test subjects yet and hasn’t released any information on what entails such a clinical trial. But it doesn’t really matter, as fans of Elon Musk have already started salivating at the thought of implanting questionable experimental technology in their brain.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
— Neuralink (@neuralink) May 25, 2023
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…
On four separate occasions since 2019, Elon Musk predicted that Neuralink would begin human trials for a brain implant to cure incurable conditions like blindness or paralysis. Yet this company, which Musk founded seven years ago, only sought to earn the approval of the FDA in early 2022. According to seven current and former employees of the company, the agency rejected the first application. The Food and Drug Administration had marked out several concerns to Neuralink that needed addressing before it sanctioned the trials on humans. Major issues included the device’s lithium battery, the probability of migrating wires inside the human brain, and the challenge of extracting the device safely. At that point, none of them had any answers.
Neuralink Has Received Approval from The FDA
Nevertheless, the approval from the FDA on May 25th came at the same time as the US legislators asking the regulators to investigate whether the entire makeup of the panel overseeing the testing of animals at Neuralink had contributed to rushed and botched experiments or not. The company’s troubles with federal investigations have already been well-documented. In 2022, the Inspector General of the USDA began investigating the potential violation of the Animal Welfare Act, which governs how researchers conduct tests on and treat animals. It has been reported that the company has killed about 1,500 animals, which includes 280 sheep, pigs, and monkeys, following experiments since 2018. The USDA inquiry has also been looking into the gross oversight displayed by USDA when it comes to Elon Musk’s company.
Back in 2021, Elon Musk had set lofty goals for the Neuralink team. He had claimed that Neuralink would be ready to test the technology of brain implants in human subjects by 2022. In 2022, he put out another press release, where he sounded a little unsure, but still confident about the impending success of his company. “We want to be extremely careful and certain that it will work well before putting a device into a human. 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.”
Will Elon Musk Fulfill His Intended Ambitions?
One can assume that Elon Musk’s lofty, and somewhat unobtainable claims have been the reason why he never received approval from the FDA for clinical trials until recently. There were no reports about the earlier rejections. But despite the recent approval, Neuralink hasn’t disclosed any details of its trial application, the extent of the concerns that the agency has, or the rejection from the FDA. As a private company, there is no real requirement to put out such regulatory interactions with the investors. During the hours-long presentation in November 2022, Musk stated that the company had already done away with most of the paperwork to the agency, without pointing to any formal application.
Interestingly, the earlier rejections from the FDA somewhat raised the difficulty for the subsequent requests for trial approval for Neuralink. The FDA has mentioned that it has approved around two-thirds of all human-trial applications for devices on the first attempt in the last three years. Moreover, what Elon Musk has in buckets, is the loyalty of his clientele. Bob Nelsen, the co-founder of venture capital firm ARCH Venture Partners, recently stated, “I definitely would never bet against him. 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.”
In his many public comments, Elon Musk has outlined the vision for Neuralink- both healthy and disabled people will be popping into neighborhood facilities for speedy insertions of devices with functions that range all the way from curing autism, obesity, and depression, to web-surfing, and telepathy. During a November 30th presentation, Musk mentioned, “I could have a Neuralink device implanted right now, and you wouldn’t even know.” In 2020, he claimed, “You’ll be able to save and replay memories. The future is going to be weird.”
Keep Reading: Elon Musk, other major tech leaders call to halt ‘giant AI experiments’
Sources
- “Elon Musk’s Brain Implant Company Neuralink Says the FDA Has Approved Human Trials.” Mashable. May 26, 2023.
- “Elon Musk’s brain implant company Neuralink approved for in-human study.” The Guardian. Reuters. May 26, 2023.
- “Elon Musk’s Neuralink brain chip has been officially approved for human trials.” UNILAD. Stewart Perrie. May 26, 2023.
- “U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks.” Reuters. Rachael Levy and Marisa Taylor. March 2, 2023.