FDA approves brain implant for human trials

Elon Musk’s brain implant company, Neuralink, is gearing up to test its technology in humans. On May 25, the company tweeted that the Food and Drug Administration approved Neuralink’s first-in-human trials for a device designed to connect human brains to computers. “It’s like a Fitbit in your skull with tiny wires,” Musk said of the technology.

The device, called the Link, consists of a tiny computer chip embedded onto the brain’s surface by a surgical robot. Once inside the brain, the Link can record and send electrical signals to an external computer, allowing a person to control the computer with his or her thoughts. Experts agree the technology could help people with neurological impairments. But questions remain: how will Neuralink receive informed consent from noncommunicative patients? And will the Link be accessible to everyone, or only wealthy patients?

Musk and a group of engineers launched Neuralink in 2016. The company first conducted animal tests of its technology in 2017, trying out the brain chip in monkeys at the University of California, Davis. A video released in 2020 showed spikes in neural activity when a pig embedded with the brain chip sniffed for food. Neuralink has faced several federal investigations into its handling of animals and hazardous materials.

Douglas Weber, a professor of mechanical engineering at Carnegie Mellon University, said he is confident the FDA wouldn’t have granted Neuralink approval to perform human clinical trials if there were any serious safety concerns.

Weber said the Link’s big advantage is that it’s fully integrated. He explained that many other brain-computer interfaces consist of two separate components, a sensor and a set of electronics. Often these devices use wires that come through the skin to connect the brain to an external computer. In contrast, the Link combines device components into a single, wireless device. “It’s just a more, I would say, mature platform for supporting applications,” said Weber.

Sumner Norman, a researcher at the science think tank Convergent Research, believes the Link could help treat localized neurological issues, such as motor neuron diseases that affect muscle activities like speaking and walking. “You can put a high number of electrodes in a highly localized area—those electrodes are very, very fast to respond,” he explained. But Norman doubts the Link can be used to treat neurological conditions that are spread throughout the brain such as depression and schizophrenia. Electrodes aren’t well-suited to treating these types of diseases and, as Norman noted, placing electrodes throughout the entire brain isn’t possible without turning it into “Swiss cheese.”

Weber hopes Neuralink’s human clinical trials will include studies of long-term effects for patients diagnosed with permanent paralysis. David Beyda is a member of the Christian Medical and Dental Associations and a professor and chair of the department of bioethics and medical humanism at the University of Arizona College of Medicine–Phoenix. He said the Link could benefit cognitively impaired patients, but he cautioned that Neuralink must first address ethical issues, specifically how the device will receive informed consent from neurologically impaired patients unable to communicate for themselves. He said that only patients who have a trustworthy advocate who can speak on their behalf, such as a family member who serves as their legal guardian, should be considered for brain-computer interfaces.

Beyda also worries about whether the Link will be affordable. If insurance companies bear the brunt of the cost, he thinks only individuals with the highest health insurance packages will have access. Norman shares Beyda’s concern, and hopes Medicare and Medicaid will help offset the costs. He said the best way to appeal to these government agencies is by proving that the Link improves individuals’ quality of life to the point of reducing their medical costs.

Neuralink isn’t the only company making waves in the field. Synchronperformed the first human brain–computer interface implant in the United States last July. Earlier this month, Precision Neuroscience tested its Layer 7 Cortical Interface in three human patients. In November 2021, Blackrock Neurotech’s MoveAgain BCI received a Breakthrough Device designation from the FDA.