Neuralink’s human trials get FDA nod

The US Food and Drug Administration (FDA) has approved Neuralink for its first in-human study. In a Twitter announcement, the California-based neurotechnology company said the FDA nod “represents an important first step that will one day allow our technology to help many people.”

Elon Musk set up Neuralink to help treat a range of health conditions and blindness and paralysis are the two leading indications. The chip, which is implanted in the brain and connects to external digital devices in what the company calls its ‘brain-computer interface,’ and has already been tested in animals.

The announcement comes in the same week as results published in Nature demonstrating a paralsyed patient walked again thanks to a brain-spine digital interface – the patient’s thoughts were transmitted to his legs.

As per Reuters, FDA rejected Neuralink’s first human-trial application in early 2022. Neuralink has addressed safety concerns that were raised at the last application, including issues around the battery, wires, and safe retrieval process of the device.

In a statement, Neuralink said it is not yet recruiting for the clinical trial. There is, however, a patient registry application for anyone in the US over 18 years old with either quadriplegia, paraplegia, vision loss, hearing loss, or the inability to speak.

Although Neuralink has made headlines for its cutting edge technology, the company has also had its fair share of controversy.

According to an investigation by Reuters, Neuralink is estimated to have killed 1,500 animals, including more than 280 sheep, pigs, and monkeys, following experiments since 2018. Sources say the number of animal deaths is higher than it should be and the company is currently under federal investigation by the US Department of Agriculture. Reports of animal testing being rushed, causing needless suffering and deaths, means the company may have violated the Animal Welfare Act. Medical Device Network