What is Neuralink?

Neuralink, which was founded in 2016, is a neurotech company that works with brain-computer interface (BCI) technology. This technology uses electronic implants to decode brain activity and transmit it to computers. According to the Washington Post, researchers hope to use BCI to restore function in people with paralysis and other debilitating conditions.

Neuralink's BCI system, called the Link, is a small circular implant that will be sewn into the surface of a patient's brain. The implant is connected to a series of threads inserted directly into brain tissue to detect neural signals.

Once the device is implanted, patients will be able to control it with an app. They will also be able to control external keyboards and mice through Bluetooth. According to Musk, the device could also be updated on a regular basis.

"I'm pretty sure you would not want the iPhone 1 stuck in your head if the iPhone 14 is available," he said.

Neuralink gains FDA approval for human clinical trials

On Thursday, Neuralink announced that it gained FDA approval to begin its first human clinical trials, an important milestone as it progresses from animal research.

According to Reuters/The Guardian, Neuralink's approval comes after several previous rejections. In March, FDA outlined several concerns that Neuralink needed to address before it could begin human trials, including issues with the device's lithium battery and whether the device could be safely removed without damaging brain tissue.

"This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people," the company said.

Although FDA typically doesn't comment on approvals for human clinical trials, an agency spokesperson on Friday said FDA "acknowledges and understands" Neuralink's announcement and that the company may now begin conducting human trials for its device.

So far, Neuralink has not indicated when it will begin its clinical trial, though it did note that patient recruitment is not yet open. On the company's website, a patient registry indicates that only individuals with certain conditions, such as paralysis, blindness, deafness, or an inability to speak, will be eligible for the trials. (Reuters/The Guardian, 5/25; Capoot, CNBC, 5/25; Bettelheim, Axios, 5/26; Gilbert/Siddiqui, Washington Post, 5/26)

Traditional provider organizations are facing a slew of disruptive innovations — and leaders are having a hard time sorting the sound from the noise. Use this infographic to answer the three most important questions to lead your organization’s disruptive innovation strategy.