FDA Clears Elon Musk's Neuralink To Trial Human Brain Chip Implants

A company backed by Elon Musk, Neuralink, has gained FDA approval to launch its first-in-human clinical study. The company stated on Twitter that it is the result of the Neuralink team working closely with the US Food and Drug Administration (FDA) and represents the first step that one day will allow the technology to help many people.

The mission of Neuralink is to create a generalized brain interface to restore autonomy to a patient with unmet needs today, and to unlock human potential tomorrow. The company says its brain-computer interfaces have the potential to change lives for the better and wants to bring that technology from the lab to the homes of patients in need. Neuralink is one step closer to doing so with its recent FDA approval, giving the company the ability to move from testing on animals to testing on human patients.

"We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study," the company tweeted. Elon Musk replied, "Congratulations Neuralink team!"

The technology has been in the works for decades, being it has the potential to restore function to patients with paralysis and other debilitating conditions such as amyotrophic lateral sclerosis. Other companies, like Blackrock Neurotech and Synchron, have implanted similar devices in patients for clinical trials, with at least 42 patients around the world having had brain-computer implants so far, according to a report by The Washington Post.

Neuralink's solution is fully implantable, cosmetically invisible, and designed to allow a person to control a computer or mobile device anywhere they go. The company touts that its N1 implant is capable of resisting physiological conditions several times harsher than those in the human body. It is powered by a small battery charged wirelessly from the outside via an inductive charger.

The N1 implant is inserted through a surgical robot with threads so fine that they can't be inserted by the human hand. The robot head contains the optics and sensors of 5 camera systems and the optics for an optical coherence (OCT) system. The needle is thinner than a human hair and grasps, inserts, and releases the threads.

Anyone who believes they may be a candidate for such a procedure can sign up for future Neuralink clinical trials via the company's Patient Registry. As of yet, there has not been any time frame given on when the trials may begin.