What were FDA’s concerns over Elon Musk’s Neuralink chip? Premium

Neuralink is making a Class III medical device known as a brain-computer interface. The device connects the brain to an external computer via a Bluetooth signal, enabling continuous communication back and forth. It could revolutionise treatment for conditions such as Parkinson’s disease, epilepsy, and spinal cord injuries.

Since its founding in 2016, Elon Musk’s neurotechnology company Neuralink has had the ambitious mission to build a next-generation brain implant with at least 100-times more brain connections than devices currently approved by the U.S. Food and Drug Administration (FDA).

The company has now reached a significant milestone, having received FDA approval to begin human trials. So what were the issues keeping the technology in the pre-clinical trial phase for as long as it was? And have these concerns been addressed?

Neuralink is making a Class III medical device known as a brain-computer interface (BCI). The device connects the brain to an external computer via a Bluetooth signal, enabling continuous communication back and forth.

The device itself is a coin-sized unit called a Link. It’s implanted within a small disk-shaped cutout in the skull using a precision surgical robot. The robot splices a thousand tiny threads from the Link to certain neurons in the brain. Each thread is about a quarter the diameter of a human hair.

If Neuralink’s BCI can be made to work safely on humans, I believe the potential benefits would make the effort worthwhile.

The company says the device could enable precise control of prosthetic limbs, giving amputees natural motor skills. It could revolutionise treatment for conditions such as Parkinson’s disease, epilepsy, and spinal cord injuries. It also shows some promise for potential treatment of obesity, autism, depression, schizophrenia and tinnitus.

Several other neurotechnology companies and researchers have already developed BCI technologies that have helped people with limited mobility regain movement and complete daily tasks.