MondayFounder

Neuralink, the groundbreaking neurotechnology startup co-founded by the visionary Elon Musk, made a groundbreaking announcement on Thursday. They revealed that they have received the highly coveted approval from the Food and Drug Administration (FDA) to embark on their inaugural clinical study involving human subjects.

Neuralink’s pioneering project revolves around the development of an extraordinary brain implant called the Link. This remarkable device aims to revolutionize the lives of patients afflicted with severe paralysis by enabling them to control external technologies solely through neural signals. The implications are awe-inspiring, as individuals suffering from debilitating degenerative diseases such as ALS could potentially regain their ability to communicate with their loved ones by moving cursors and typing using their thoughts.

In a tweet, the company expressed its jubilation, acknowledging the remarkable efforts of the Neuralink team in collaboration with the FDA. They also emphasized the significance of this pivotal first step, which will undoubtedly pave the way for their groundbreaking technology to bring relief and assistance to countless individuals in the future.

As of now, neither the FDA nor Neuralink has responded to CNBC’s request for additional comments. The exact scope and parameters of the approved clinical trial remain undisclosed. Neuralink did, however, reveal through a tweet that patient recruitment for the trial has not yet commenced.

Neuralink operates within the emerging industry of brain-computer interfaces (BCI). A BCI system is designed to decode brain signals and translate them into commands that can operate external technologies. Thanks to the remarkable prominence of Elon Musk, who is not only the co-founder of Neuralink but also the CEO of Tesla, SpaceX, and Twitter, the company has become a household name in the BCI space.

Scientists have been diligently studying BCI technology for several decades, and various companies have made promising strides toward bringing their systems to market. However, securing FDA approval for a commercial medical device is an arduous task, requiring rigorous testing and thorough collection of safety data. No BCI company has yet managed to obtain the final seal of approval from the FDA. Nevertheless, Neuralink’s recent milestone of receiving approval for a study involving human patients propels them closer to their ultimate goal.

The BCI developed by Neuralink necessitates invasive brain surgery for patients. The centerpiece of their system is the Link, a compact circular implant responsible for processing and translating neural signals. Connected to the Link are a series of slender, flexible threads that are inserted directly into the brain tissue, detecting neural signals.

Patients equipped with Neuralink devices will acquire proficiency in controlling them through the Neuralink app. Once mastered, patients will have the ability to manipulate external devices such as mice and keyboards through a Bluetooth connection, as detailed on the company’s website.

The FDA’s approval of an in-human study marks a significant triumph for Neuralink, especially after encountering a series of recent challenges. In February, the U.S. Department of Transportation confirmed an investigation into Neuralink’s alleged unsafe packaging and transportation of contaminated hardware. Furthermore, Reuters reported in March that the FDA initially rejected Neuralink’s application for human trials, outlining numerous issues that needed to be addressed.

Neuralink has also faced criticism from activist groups regarding their treatment of animals. The Physician’s Committee for Responsible Medicine (PCRM), an organization advocating against animal testing, has repeatedly urged Elon Musk to disclose details regarding experiments on monkeys that reportedly resulted in internal bleeding, paralysis, chronic infections, seizures, psychological decline, and even death.

At present, the PCRM has not responded to CNBC’s request for comment on these matters.

Beyond assisting patients with paralysis, experts foresee BCIs playing a pivotal role in treating conditions such as blindness and mental illness in the future. Elon Musk has expressed his vision for Neuralink to explore these potential applications, not only for those with medical conditions but also for healthy individuals.