Neuralink, a neurotechnology company founded by Elon Musk in 2016, has achieved a milestone by receiving FDA approval to begin human trials. However, there are still issues that need to be addressed before the technology can be used in clinical trials.
Neuralink is making a Class III medical device called a brain-computer interface (BCI) that connects the brain to an external computer via a Bluetooth signal. The device is implanted within a small disk-shaped cutout in the skull using a precision surgical robot, which splices thousands of tiny threads from the Link to certain neurons in the brain. Each thread is about a quarter the diameter of a human hair.
Potential benefits
Neuralink’s BCI could revolutionize treatment for conditions such as Parkinson’s disease, epilepsy, and spinal cord injuries. It could also be used to treat obesity, autism, depression, schizophrenia, and tinnitus. Other neurotechnology companies and researchers have already developed BCI technologies that have helped people with limited mobility regain movement and complete daily tasks.
The long road to approval for human trials
Neuralink announced in February 2021 that it was working with the FDA to secure permission to start initial human trials. In March 2022, Neuralink made a further application to the FDA to establish its readiness to begin human trials. On 25 May 2023, Neuralink finally received FDA approval for its first human clinical trial. This approval comes less than six months after the US Office of the Inspector General launched an investigation into Neuralink over potential animal welfare violations. The FDA had a list of issues that needed to be resolved before human trials could commence, most of which called for Neuralink to perform thorough and repeated testing and data collection over an extended period. It can be said with certainty that all of the issues have been fully resolved, but considering the rigor of the FDA’s approval process, we might conclude they have been resolved to a point of satisfaction for the FDA.
Risks
A precision robot known as Implant/r1 performs the surgical procedure to implant the Neuralink BCI. This robot surgeon had to be put through its paces to gather evidence that it could reliably and safely implant and remove the Neuralink BCI without damaging surrounding brain tissue or creating the risk of infection, bleeding, inflammation, or scarring. Once implanted, the Neuralink BCI must function as intended and not cause unwanted side effects such as seizures, headaches, mood changes, or cognitive impairment. Overheating lithium-ion batteries can pose a great risk to BCI users. The longevity of the battery was also taken into account, as well as how easy it would be to safely replace from its position under the skin behind the ear. Additionally, there is the risk of wire migration, as the Link consists of a disk-shaped chip with very thin wire electrodes that connect to neurons in the brain.