Written by: Mark Rubinshtein, Ph.D.

Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device. Recruitment for the clinical trial has not yet started.

The Neuralink device is approximately the size of a coin, measuring about 23 mm x 8 mm. The implant includes several chips, a battery, and other electronic components. Threads thinner than a human hair protrude directly from the device and go directly into the brain. Signals from the implant are sent via Bluetooth to a brain-computer interface, which can enable a person to control a robotic limb or move an on-screen cursor. The device is inserted into the brain using a surgical robot.

In an online interview in 2021, Musk stated that the device is “like a Fitbit in your skull with tiny wires that go to your brain.” The device may improve the quality of life for disabled persons, for example, restoring body functionality those with spinal cord injuries.

The Neuralink device is a Class III medical device, examples of which include breast implants and implantable pacemakers. Neuralink has previously demonstrated the use of its device in animals, stimulating movement in a pig and enabling a macaque to play Pong. The FDA rejected Neuralink’s application for human trials in 2022, citing several safety concerns.

Neuralink is the Assignee of several patents relating to brain-machine interface technology. These include U.S. Pat. Nos. 11,103,695 and 11,630,516.