Neuralink Wins FDA Approval for Human Trials
Neuralink, Elon Musk’s brain implant company, has received approval from the Food and Drug Administration (FDA) to begin human trials for its device. Neuralink is one of the many neurotech companies that aims to merge humans with machines to cure medical conditions like depression, paralysis, and blindness, as well as enhance abilities such as memory and thought-based computer interaction.
Founded in 2016, Neuralink has developed a “Link” device that can directly interface with the human brain using ultra-flexible, small electrodes implanted directly into the brain tissue to receive communication between neurons to allow users to communicate with technology by thought alone. The Link is implanted using a robot that works like a neural sewing machine. Bradley Greger, a neuroscientist, explains that there are numerous ways this technology can restore lost human abilities to damaged or diseased patients or enhance existing abilities, as seen in individuals with limiting conditions such as blindness and hearing loss. Companies such as Blackrock Neurotech and Synchron have already begun human tests for Parkinson’s disease and similar conditions, while Neuralink receives more significant media attention due to Musk’s well-funded connection. This public attention has drawn regulators’ scrutiny regarding Neuralink’s potentially unsafe animal research practices and ardent goals to enhance human performance.
In May 2021, Neuralink made an announcement that it had obtained FDA approval to launch its “in-human clinical study.” The company stated that this decision marks a crucial first step towards achieving its ultimate goal that would eventually help many people, and that this announcement was due to the remarkable work of the Neurolink team. Musk predicted human trials’ progress in November 2020, with the FDA reportedly rejecting an initial application due to safety concerns.
Neuralink’s animal research practices drew intense scrutiny, leading to a Department of Agriculture investigation into potential animal welfare violations. Additionally, it has reportedly come under investigation by the Department of Transport for allegedly transporting contaminated devices removed from monkeys in an unsafe manner.
What to Watch For
While Neuralink seeks to restore human abilities where they have been lost, Musk hopes to use neurotechnology to enhance capabilities and add new ones. Experts believe this raises existential ethical concerns such as mental privacy and the potential of using technology on otherwise healthy individuals. Cristin Welle, one of the scientific advisors of Neurotech firm NeuroOne, concurs with Bradley Greger that such goals are still in the earlier stages of development due to current technological limitations that would need to be overcome. Experts believe that better opposition and discussion are needed in regards to data gathering from individual brains and regulation since large for-profit companies such as Neuralink could profit extensively from such data.
Rafael Yuste, Columbia Neurobiologist, points out the necessity for ethical regulations and discussions surrounding neurotech, particularly for devices such as non-implantable devices or brain-computer interfaces. Yuste explains that neuroscientists are growing increasingly more capable of decoding brain activity and using the information gleaned from this to develop solutions for the field. Nonetheless, he points out that mental privacy is crucial and must be protected.
What We Don’t Know
It remains unclear when Neuralink will commence its trial or if and when it will release a product. The company states that it has not yet recruited participants, though the patient registry on the company website suggests that they may have a particular interest in recruiting patients with certain types of paralysis, vision loss, hearing loss, or speech inability. While starting human trials is a crucial milestone for receiving FDA approval, the trials are typically early feasibility studies that may enroll less than ten patients and may only last six to 12 months. Positive results would enable Neuralink to initiate later, more significant trials that would demonstrate the efficacy and safety for whichever condition they intend to treat, a process that Welle believes could last years.
According to Forbes’ real-time tracker, Musk’s net worth is estimated at $206.7 billion. Musk is the world’s second richest person after French luxury magnate Bernard Arnault. Alongside Neuralink, Musk has co-founded Tesla, SpaceX, and Boring Company and holds a significant stake in social media platform Twitter.
The field of neurotechnology has recently been under much scrutiny, leading to some failures that highlight its high human costs. However, other entrepreneurs looking to enter the field have been working hard, such as Phillip Alvelda, who raised $8 million to build a next-generation brain implant in 2020.