Elon Musk’s Neuralink secures FDA clearance for brain-chip human trials

Neuralink, Elon Musk’s brain implant startup, received approval for human trials from an independent review board of the U.S. Food and Drug Administration (FDA). According to a company blog published on Tuesday, interested patients can start registering on Neuralink’s website.

The so-called Precise Robotically Implanted Brain-Computer Interface (PRIME) study will assess both the safety and effectiveness of the implants. The company aims to first test its wireless brain-computer interface on paralysed patients, to ultimately develop devices for people with various neurological conditions. Those with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) could qualify for the six-year-long study. A chip, surgically implanted by a robot in the part of the brain that controls motion, will pick up and transmit signals, allowing patients to control a keyboard with their thoughts.

Why does it matter?

This significant announcement marks a milestone for the biotechnology startup, which has progressed towards human trials since 2019. Initially, in early 2022, the FDA denied the company’s human trial application. Neuralink faced an uphill battle in securing FDA approval due to safety concerns related to the device’s lithium battery, components’ possible migration to other parts of the brain, and potential damage to the brain tissue when removed. An FDA clearance means that Neuralink has addressed all the safety concerns. Human trials represent a significant leap in neuroscience and biotechnology and have the potential to improve lives. Elon Musk’s venture opens up a myriad of future applications and possibilities when combined with AI, but it also raises challenging ethical, privacy, and security questions that humanity will need to resolve.