Neuralink receives FDA clearance to begin human trials of its brain-computer interface (Updated)
The BCI startup remains under federal investigation for potential violations of the Animal Welfare Act.
Turns out Elon Musk's FDA prediction was only off by about a month. After reportedly denying the company's overtures in March, the FDA approved Neuralink's application to begin human trials of its prototype Link brain-computer interface (BCI) on Thursday.
Founded in 2016, Neuralink aims to commercialize BCIs in wide-ranging medical and therapeutic applications — from stroke and spinal cord injury (SCI) rehabilitation, to neural prosthetic controls, to the capacity "to rewind memories or download them into robots," Neuralink CEO Elon Musk promised in 2020. BCIs essentially translate the analog electrical impulses of your brain (monitoring it using hair-thin electrodes delicately threaded into that grey matter) into the digital 1's and 0's that computers understand. Since that BCI needs to be surgically installed in a patient's noggin, the FDA — which regulates such technologies — requires that companies conduct rigorous safety testing before giving its approval for commercial use.
In March, the FDA rejected Neuralink's application to begin human trials reportedly in part due to all the test animals that kept dying after having the prototype BCI implanted. According to internal documents acquired by Reuters in December, more than 1,500 animals had been killed in the development of the Neuralink BCI since 2018. The US Department of Agriculture's (USDA) Inspector General has since launched an investigation into those allegations.
The FDA's reticence was also born from concerns about the design and function of the interface when implanted in humans. "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," current and former Neuralink employees told Reuters in March.
While Neuralink has obtained FDA approval to begin its study, the company is not yet seeking volunteers. 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," Neuralink Tweeted on Thursday. "Recruitment is not yet open for our clinical trial."
Update, 05/26/23, 11:28 AM ET: This story has been updated to include a response from Physicians Committee for Responsible Medicine, the animal welfare advocacy group that previously uncovered Neuralink's animal deaths.
On May 25, 2023, Elon Musk’s brain-computer interface company Neuralink shared via Twitter that it had received approval from the FDA to begin human clinical trials. It is important to remember that such FDA approval is not an acquittal of Neuralink’s well-documented track record of animal cruelty and sloppy scientific studies. The approval is also not a guarantee that a Neuralink device will someday be commercially available as a significant number of medical devices that begin clinical trials never reach the market. In addition, Neuralink will likely continue to conduct experiments on monkeys, pigs, and other animals even after clinical trials have begun. Past animal experiments revealed serious safety concerns stemming from the product’s invasiveness and rushed, sloppy actions by company employees. As such, the public should continue to be skeptical of the safety and functionality of any device produced by Neuralink.
The Physicians Committee continues to urge Elon Musk and Neuralink to shift to developing a noninvasive brain-computer interface. Researchers elsewhere have already made progress to improve patient health using such noninvasive methods, which do not come with the risk of surgical complications, infections, or additional operations to repair malfunctioning implants. Noninvasive devices are already demonstrating the ability to improve quality of life for older adults and elderly patients, translate brain activity into intelligible speech, and assist paralyzed patients.
