Elon Musk is confident his brain implant company Neuralink will make the paralyzed walk, the blind see and eventually connect humans to computers. But so far, the company has been denied permission to conduct clinical trials with the relatively modest goal of helping people with disabilities.
Since 2019, Elon Musk has predicted at least four times that his company, Neuralink, will soon begin human trials of a revolutionary brain implant to treat conditions like paralysis and blindness. However, the company, which was founded in 2016, only applied for approval from the US Food and Drug Administration (FDA) in early 2022, and the authority has now rejected the application.
In justifying its decision, the FDA outlined dozens of issues the company must address before conducting human testing, which is an important milestone on the road to the final product. One of the FDA’s biggest claims is the possibility that the tiny electrodes could migrate to other areas of the brain. These wires can cause inflammation, impair function in critical areas of the brain, and rupture blood vessels, even leading to death.
The FDA’s concerns about the remote charging system for the implant’s lithium batteries are also not unfounded – if the battery overheats and fails, brain damage can occur. The device itself can also overheat during operation, causing damage to brain tissue. The FDA also questioned whether it would be possible to remove the device without damaging the brain.
Neuralink has been busy fixing the issues identified by the FDA. However, there are serious doubts that the company will be able to resolve these quickly and fulfill Musk’s promise to begin human trials in the spring. According to FDA statistics, on average, the agency only approves 66% of human trial applications on the first attempt, but after reapplications, the number of approvals reaches 85%. Companies approved for human testing typically conduct at least two rounds of testing before applying for FDA approval. But such slowness doesn’t suit Musk.
“I could implant a Neuralink device right now and you wouldn’t even know it”Elon is sure. He recently stated that he was so confident in the safety of the devices that he was willing to implant them in his children. He also promised that Neuralink would restore full mobility to paralyzed patients.
According to industry and regulatory experts, Neuralink could eliminate all of the FDA’s claims by conducting slower phase studies, but that approach doesn’t conform to Musk’s rules.
The dispute between Musk and the FDA stems from a federal investigation into the premature move to animal testing, which has resulted in additional suffering and death for many pigs, sheep and monkeys. The Department of Transportation is separately investigating whether Neuralink legally transported dangerous pathogens on monkey brain implants without proper safeguards.
While Neuralink gets a lot of attention for its famous founder, more than a dozen companies develop or manufacture devices that record or stimulate neural activity — so-called neuromodulatory devices — which have a $6 billion market. Experiments with such devices have been going on for more than four decades. The FDA has approved a significant number of them, including for the treatment of Parkinson’s disease, epilepsy, and obsessive-compulsive disorder.
Neuralink competes in the niche of so-called Brain Computer Interface (BCI) devices. These devices use electrodes connected to or on the surface of the brain to connect directly to a computer. The FDA has not yet granted final marketing approval for the BCI brain implant.
Musk’s company is behind at least one competitor in the race for FDA approval. Synchron has received FDA approval for human trials. Like Neuralink, Synchron aims to help paralyzed people with mental typing. Last summer, Musk, who found himself in the role of a catch-up, even approached Synchron with an investment proposal, but was turned down.
Neuralink may be helped by federal legislation in recent years aimed at speeding up the processing of applications at the FDA. Among other changes, the groundbreaking device program has forced the agency to significantly reduce the overall time it takes businesses to obtain permits. The FDA now has 30 days to respond to requests.
Of the 750 devices currently considered breakthrough devices, more than 100 are neurological, according to the FDA. Neuralink received designation for its brain implant in July 2020. Neuralink expected the FDA to approve testing on 10 people by December 2021, which would result in a result “First people amazing experience”.
It is noteworthy that many Neuralink employees describe the working environment in the company as too lax and disorganized, despite the high demands and ambitions. Elon himself often pays more attention to his other ventures — Tesla, SpaceX, and Twitter — than Neuralink. Musk appears to have expected Neuralink to perform similarly to Tesla, which quickly launched several groundbreaking electric vehicles. “Elon cannot understand that this is not a car, says neuroscientist Gene Civilico. — This is the human brain. It’s not a toy.”
Neuralink is far from the only brain implant pioneer struggling through difficult research and regulatory challenges that could drag on for years, says Jean: “The reason we don’t have a device like Neuralink yet isn’t because nobody wanted to invest in it, nor because, that Elon Musk didn’t think about it enough. It’s just a difficult and complex task.”