Neuralink, Elon Musk’s brain implant company, has won approval from the U.S. Food and Drug Administration to start testing its device in humans, one of a growing cadre of neurotech pioneers with goals of merging humans with machines to treat a range of medical conditions such as paralysis, blindness and depression—and enhance existing abilities like memory or allow us to interact with computers by thought alone.
Key facts
Neuralink was founded quietly in 2016 and flew mostly under the radar until showcasing its technology in 2019.
It is building a device that can directly interface with the human brain—called the “Link,” a sort of brain chip Musk has described as a “Fitbit in your skull”—and a robot that can automatically implant it like a kind of neural sewing machine.
Its device makes use of “ultra-flexible, tiny electrodes implanted directly into the brain tissue to ‘listen’ to the communication between neurons,” Cristin Welle, a neurophysiologist at the University of Colorado, told Forbes, which could allow users to control a computer or other devices or communicate by simply thinking.
Neuralink is not the only company doing this or even the most advanced—brain implants for conditions like Parkinson’s disease are already in widespread use and similar firms like Blackrock Neurotech and Synchron have already started human tests, the former decades ago—but receives more media attention because it is well-funded and has a connection to Musk rather than having a novel or technically astounding device, Columbia neurobiologist Rafael Yuste told Forbes.
By allowing the human brain to directly interface with computers and other devices, neurotech companies hope they can help people regain abilities lost through things like injury or disease. For example, a camera could be used to stimulate areas of the brain associated with vision to restore sight or a robot limb could be connected to an area of the brain that controls movement.
Bradley Greger, a neuroscientist and neural engineer at Arizona State University, told Forbes there are many different ways this can be achieved, meaning “there is a lot of space for multiple companies” to make a mark.
News peg
In late May, Neuralink announced it had secured U.S. FDA approval to launch its first “in-human clinical study.” The decision “represents an important first step that will one day allow our technology to help many people,” the firm said, adding that it was the result of “incredible work” by the Neuralink team. The news comes after Musk, who sets notoriously optimistic timelines and has a history of prematurely celebrating success with regulators, predicted trials were six months away in November. It was not the first time Musk had predicted human trials were around the corner and the FDA reportedlyrejected an application from Neuralink over safety concerns earlier this year. The FDA took the unusual step of confirming its assent for Neuralink to begin human tests in a statement to media outlets, though beyond noting it had greenlit human trials with the company’s brain implant and surgical robot it did not provide details.
Tangent
Neuralink has come under intense scrutiny over its animal research practices and is reportedly being investigated by the U.S. Department of Agriculture for potential animal welfare violations, which the company denies. It is also reportedly the subject of a federal probe from the Department of Transport for allegedly transporting contaminated devices removed from monkeys in an unsafe manner.
What to watch for
Musk’s vision for Neuralink goes beyond what many in the field seem to be aiming for and he is open about wanting to not only restore human performance where it is lost but to enhance or add new functionality as well. Experts say using neurotechnology for enhancing human abilities raises more profound ethical questions than restoration, particularly as it would be used on otherwise healthy individuals. Greger said such goals are “very speculative” and are likely a long way away. Welle, who is also on the scientific advisory board of neurotech firm NeuroOne, concurred and said many limitations to current technology still need to be overcome, such as electrode breakage and the need to recalibrate algorithms regularly. Data gathering from people’s brains will become a key issue and there is a “dire need” for better regulation and discussion in this area, Welle said, particularly regarding large for-profit companies like Neuralink that stand to “make huge amounts of money off this type of data.”
Crucial quote
Yuste also believes there is an urgent need for regulation and ethical discussion for neurotech. The threat largely comes from the companies developing non-implantable devices or brain-computer interfaces that are treated more like consumer electronics, Yuste said, rather than implantable devices from the likes of Neuralink, which are treated as medical devices and are governed by strict medical ethics and robust regulations. Chile is the first country to enshrine protection for brain activity and its information and should serve as an example for the rest of the world, Yuste said. “The brain is not just another organ,” he explained, adding that neuroscientists “are increasingly able to decode brain activity and use that information” for research and in the clinic. “Mental privacy is the sanctuary of our minds, and should be protected at the global level.”
What we don’t know
It’s not clear when Neuralink’s trial will begin or if and when it will ultimately launch a product. The firm said it has not started recruiting participants yet and will “announce more information” on recruitment soon. A patient registry on the company’s websitesuggests Neuralink may be looking to recruit patients with certain types of paralysis, vision loss, hearing loss or the inability to speak. Greger told Forbes starting human trials is a “significant milestone to receiving FDA approval,” which he said is “mission critical” for Neuralink. It is, however, the first step of many on a long road that has no guarantee of success. “These are really early trials, often called early feasibility studies, that typically enroll less than 10 patients” and generally last between six and 12 months, Welle, who is also a former FDA official, told Forbes. Positive results would then allow Neuralink to start the larger trials needed to demonstrate safety and efficacy for whatever condition they are treating, which could last years. “Rollout is years, if not decades, away,” Welle said. Once approved, however, it “becomes a readily available treatment option similar to a heart pacemaker,” Greger said.
Forbes valuation
$206.7 billion USD. That’s Musk’s estimated net worth, according to Forbes’ real time tracker. He is the second richest person in the world, trailing only French luxury goods magnate Bernard Arnault. In addition to Neuralink, Musk cofounded electric carmaker Tesla, the source of much of his wealth, as well as rocket firm SpaceX and tunneling firm Boring Company. He also holds a sizable stake in social media platform Twitter, which he controversially bought for $44 billion USD last year and has since implemented a series of drastic and divisive changes.
Further reading
Abandoned: The human cost of neurotechnology failure (Nature)
Move Over, Elon: This Under 30 CEO Just Raised $8 Million To Build A Next-Generation Brain Implant (Forbes )
