Did FDA approve Neuralink?
Yesterday, Neuralink, a neurotech startup co-founded by Elon Musk, announced that they had received U.S. Food and Drug Administration’s approval for initializing the first in-human clinical study.
Neuralink is currently developing a brain implant called the Link, a BCI-based (Brain–Computer Interface) technology aimed at creating the ability for people with paralysis and severe degenerative diseases to control external devices with their thoughts and neural signals.
What is the “Link” of Neuralink?
The Link by Neuralink is a small, wireless device about the size of a quarter. It consists of two key components- a cheap implant in a patient’s brain and a transmitter under the skin. Electrodes stand behind recording electrical signals from the brain. Afterward, the transmitter sends signals to a computer, allowing the control of external devices.
How many times did Neuralink get FDA rejection?
Despite being established in 2016, Neuralink did not initially approach the FDA for permission until early 2022. The reasons for the U.S. Food and Drug Administration’s rejection of Neuralink’s first application were because of health and safety concerns. First, there was a possibility that the device’s tiny threads could migrate to the other parts of the human brain through electrodes and damage the brain tissue. Safely extracting the device without further damaging the brain was another significant challenge. A primary concern was the device’s lithium battery, which could overheat and cause burns to the patients during the clinical trials. The main health problems connected with the failure of these devices were meningitis and encephalitis.
After addressing several of these concerns and continuously developing the device, Neuralink came up with a new thread design that reduced its risk of migrating to other brain areas. Neuralink has also developed new methods for safely extracting the device.
Will the FDA’s approval impact the clinical research industry and Contract Research Organizations (CROs)?
One significant clinical research industry change is that CROs specializing in medical device research could see new development opportunities and emerging demand for their services. Neuralink’s approval would pave the way for other companies to develop and market brain-computer interfaces (BCIs). Contract Research Organizations with solid experience in BCI research will take the position of bringing these products to market.
Another crucial point is that CROs like NoyMed providing clinical trial management could also see increased demand for their services. Neuralink’s approval from the FDA would gradually demonstrate that BCIs could be safe and effective for human use, as there are still many controversial and doubtful ideas regarding such an innovation. However, at one point, companies would choose to conduct clinical trials for their BCIs, increasing the need for full-service CROs.
Finally, CROs specializing in regulatory affairs could also see a growing demand. Neuralink’s approval will provide “guidelines” for other firms on obtaining FDA approval for BCIs. CROs with a prominent background in regulatory affairs would be well-positioned to help these companies navigate the FDA approval process.
Summary
Getting approval from the FDA is a significant milestone for Neuralink. Such a beginning to a revolution in the clinical research industry is focused not only on helping patients with severe degenerative disorders, such as epilepsy or paralysis, but change the way we control our brains and create new opportunities. Neuralink is likely still preparing for the trial, as there is no further information regarding when it will begin the trials or its patient recruitment activities.