Neuralink Approved for First International Trial

Elon Musk’s brain-computer interface (BCI), Neuralink, has been approved by Health Canada to begin its first clinical trial in the country.

The trial will be conducted at the University Health Network in Toronto.

“We are thrilled to announce that we have received approval from Health Canada to launch the CAN-PRIME Study, our first international trial,” reads a statement from the startup company. “This investigational medical device trial for our fully-implantable, wireless brain-computer interface (BCI) builds upon the successes of our ongoing PRIME Study in the U.S. and marks an important step towards developing innovative BCI technology that has the potential to transform the lives of individuals with neurological disorders around the world.”

“Similar to the PRIME Study, the CAN-PRIME Study aims to evaluate the safety of our implant and surgical robot and assess the initial functionality of our BCI for enabling people with quadriplegia to control external devices with their thoughts. The trial is currently open to Canadian residents with limited or no ability to use both hands due to amyotrophic lateral sclerosis (ALS) or cervical spinal cord injury.”

The Neuralink chip has already been implanted in two people in the United States. The first implant occurred in January and the second implant occurred in August.

Neuralink received FDA approval to launch its first clinical study in the U.S. in 2023. The FDA previously rejected Neurlink’s request for a human trial, citing “growing employee concern that the company is rushing experiments, causing additional suffering and deaths of pigs, sheep, and monkeys.”