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.
Clinical Trial, Elon Musk, implant, Musk, Neuralink
By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.