Musk’s Dreams Closer to Reality, Neuralink Receives FDA Approval for Human Trials After Overcoming Safety Concerns

Elon Musk’s start-up, Neuralink, announced on Thursday that it has finally secured approval from the Food and Drug Administration (FDA) to conduct its first-in-human clinical study. The approval marks a significant milestone for the company, which faced numerous challenges in obtaining authorization due to safety concerns.

Although the FDA has not yet commented on Neuralink’s announcement, the California-based startup shared the news on Twitter. “We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!,” the tweet read. “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.”

Neuralink’s brain implant technology aims to restore people’s mobility and vision by connecting brain signals to computers, potentially enabling a form of telepathy. The implant, a chip the size of a small coin, interprets brain signals and relays them to devices via Bluetooth, allowing direct communication between the brain and computers. This innovation could prove life-changing for individuals who are paralyzed or suffering from neurological diseases.

In November, Musk had promised that Neuralink was about six months away from its first human trial. While the company was behind schedule at the time, the recent FDA approval brings Musk’s pledge closer to reality. Neuralink has not yet opened recruitment for the trial but promised to provide more information soon.

The company’s journey to this point has been marked by delays and controversy. Initially, Neuralink projected it would begin implanting chips in human brains in 2020, but the timeline was pushed back several times. In December, the company faced allegations of animal welfare violations during its testing on monkeys, which it has denied.

Despite these setbacks, Neuralink’s clinical trial is set to follow in the footsteps of Synchron, another company that received FDA approval for a human trial of its brain-computer interfaces in 2021. The first such human implant was completed in July of that year. Additionally, European researchers have made significant progress in the field, with a Dutch paralyzed man regaining the ability to walk through technology that restored communication between his brain and spinal cord. However, no such device has been made commercially available yet.

This report was published by BBC.com.