Neuralink Gets Approval from FDA

On May 26th, Neuralink posted that it had gained approval from the US Food and Drug Administration (FDA) to launch a clinical trial on human patients for its brain implant. This is a momentous occasion for the start-up, as it is their first-in-human clinical study.

Trials until now

It is human nature to get inspiration from fiction, and science-fiction-esque neurotechnology company Neuralink, co-founded by Elon Musk in 2016, has been on a mission to build a direct connection between the human brain and technology. Musk expressed that the company will be able to make human telepathy a reality, offering the ability to control a computer or play games with mere thoughts.

Bold claims, but a recent report of a 29-year-old quadriplegic with a Neuralink implant on his brain showed otherwise. The patient has shown that, with the help of the implant, he can now play Pong via his thoughts.

Thus far, Neuralink has only performed clinical trials on animals. The company and Musk came under scrutiny and accused of animal abuse as reports suggest at least 15 out of 23 monkeys involved in trials between 2017 and 2020 died, many due to complications from the brain implants, including infections and device malfunctions.

However, the allegations remain mere allegations. In the summer of 2023, the FDA closed its investigation, stating it found no evidence of animal abuse or violation of animal research rules, except for a self-reported incident in 2019.

We have received Breakthrough Device Designation from the FDA for Blindsight.

Join us in our quest to bring back sight to those who have lost it. Apply to our Patient Registry and openings on our career page https://t.co/abBMTdv7Rh

— Neuralink (@neuralink) September 17, 2024

What the future holds

Human trials and experiments have always been gray areas; they evoke feelings of both fright and excitement. Subjects for Neuralink will be implanted with a brain-computer interface chip, which would require brain surgery. According to the company, the patient will be able to control keyboards or mice using merely their thoughts via a Bluetooth connection.

Neuralink’s claims are heavy, but the potential it holds to enhance the lives of millions who suffer from disabilities like ALS is enormous. Currently, trials will be conducted for Neuralink’s Blindsight device, which, according to Musk, will “enable those who have been blind from birth to see for the first time.”

YouTube: Shape the Future of Assistive Technology with Neuralink

Photo credit: The feature image is symbolic and has been done by Gorodenkoff.
Source: Futurism /  Rachael Levy (Reuters) / Elon Musk (X)