Elon Musk's neuralink takes big step forward with FDA approval for brain study

Elon Musk’s brain-implant company, Neuralink, is beginning human trials.

With the green light from the Food and Drug Administration on Thursday, it can now move forward with its first in-human clinical study in what has been a long and challenging road to the clinic.

---

Elon Musk's brain chip raises concerns about transparency and ethics

Raised ethical concerns (Image via Pexels/Furkan)

Neuralink was founded in 2016 with the goal of developing a brain implant to treat severe conditions like paralysis and blindness. Despite Musk's predictions since 2019 that the company would begin human trials, it only sought FDA approval in early 2022.

The agency initially rejected the application, citing concerns about the device's lithium battery, the possibility of the implant's wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.

Thursday's FDA approval is a critical step forward for Elon Musk and his company, which has already been the subject of federal investigations. The company has killed about 1,500 animals in experiments since 2018, leading to an investigation by the USDA's inspector general for potential violations of the Animal Welfare Act.

---

What will Neuralink do?

Musk has said that he believes brain implants could eventually cure a range of conditions, including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy.

In a tweet on Thursday, Neuralink said that it's not yet open for a clinical trial, but that the FDA approval represents an important first step towards helping many people.

Musk has publicly outlined an ambitious plan for Neuralink, and his confidence in the device's safety is so high that he has said he would be willing to implant them in his own children.

As lawmakers urge regulators to investigate the makeup of the panel overseeing animal testing at Neuralink, it remains to be seen how the company will navigate these challenges and bring its vision to fruition.

However, with FDA approval for its first-in-human clinical study, it has taken a significant step forward in the development of its brain implant device.