The tech startup known as Neuralink just received approval from the Food and Drug Association to conduct its first human clinical trial. The company makes a cosmetically invisible microchip that’s implanted into the brain. The creators, including billionaire founder Elon Musk, believe it will soon let users control a computer or mobile device wherever they go. It may also be used to treat blindness, paralysis, and help people with disabilities use technology. The latest approval frees the company from having to test its products on animals.
Neuralink announced the FDA’s decision on Twitter and wrote that the approval “represents an important first step that will one day allow our technology to help many people.” However, the startup didn’t disclose the details of the upcoming study and said it is not actively recruiting participants just yet.
The FDA acknowledged the regulatory approval, but it declined to release more details about the technology. The news comes as Neuralink is being investigated for possibly rushing the testing process. Last year, several employees told Reuters that the company was rushing and botching surgeries on monkeys, pigs, and sheep, resulting in a large number of animal deaths. In one case, the company allegedly put the wrong-sized devices into 25 pigs, forcing the staff to kill them off.
As recently as last month, several U.S. lawmakers asked regulators to look into the Neuralink panel that oversees the startup’s animal testing. The U.S. Dept. of Transportation is also investigating the company for possibly transporting dangerous pathogens on microchips that were improperly removed from monkey brains. Finally, the U.S. Dept. of Agriculture is investigating the company for possible animal welfare abuses.
In total, Neuralink has killed some 1,500 animals, including 280 sheep, pigs, and monkeys since it started experimenting on animals in 2018.
The data collected via the animal trials was used to support the company’s application for human trials. But experts say this data may be flawed because of how it was collected.
Victor Krauthamer, a biomedical engineering professor who worked at the FDA for 30 years, said the agency doesn’t typically inspect company facilities as part of the approval process.
“If the animal testing is unreliable, then (human trial) approval may be based on flawed animal safety data. The FDA should have verified their trust of animal study results,” Krauthamer told Reuters.
Neuralink originally applied for a human trial involving 10 patients, but the company revised that number after the FDA expressed concerns. This isn’t the first time the company has applied for human testing approval. It applied for human testing back in 2022 but the FDA denied the application in March. When it issued that ruling, the FDA pointed out several safety concerns that needed to be fixed. The agency reportedly raised concerns about the device’s lithium battery, the possibility of the wires migrating within the brain, and the challenge of safely extracting the brain implant.
Now that the company can proceed with the human trials, it was recently valued at $5 billion despite the regulatory hurdles ahead.
“A study to assess safety and tolerability is in no shape or form valid to justify a $5 billion valuation,” said Arun Sridhar, a scientist and entrepreneur who specializes in neuromodulation. He recently called the valuation “bonkers” based on the current state of the technology.
Several experts were caught off guard by the news of the FDA approval, considering the company’s mixed reputation when it comes to safety. Musk, in particular, is known for moving fast when it comes to technological development.
“I was surprised,” said Laura Cabrera, a neuroethicist at Penn State’s Rock Ethics Institute. “Is he going to see a brain implant device as something that requires not just extra regulation, but also ethical consideration?” she said of Musk. “Or will he just treat this like another gadget?”
Musk has even claimed that the device can be used to store thoughts, like a “backup drive for your non-physical being, your digital soul,” the billionaire said.
“I would love to know what the FDA was thinking,” L Syd M Johnson, a neuroethicist at the Center for Bioethics and Humanities in SUNY Upstate Medical University, told The Guardian. “One of the concerns about Neuralink is that it’s not functioning in the way that many other research laboratories or organizations function. There’s concerns about the potential that they are performing a kind of sloppy work and that their data may not be reliable.”