Elon Musk’s brain implant company Neuralink says it has US approval to begin trials in people
Elon Musk’s brain implant company Neuralink says it has received clearance from US regulators to begin testing its device on humans.
The company announced this on Twitter on Thursday evening, but did not provide any information about a possible study that was not listed in the US government’s clinical trials database.
Food and Drug Administration officials would not confirm or deny whether the agency granted the approval, but press secretary Carly Kempler said in an email that the FDA “acknowledges and understands” that Musk’s company made the announcement.
Neuralink is one of many groups working on connecting the nervous system to computers, with efforts to treat brain disorders, overcome brain injury, and other applications.
For example, earlier this week researchers in Switzerland published a paper in the journal Nature describing an implant that restores communication between the brain and spinal cord and helps a paralyzed man stand and walk naturally. According to Clinicaltrials.gov, more than 30 brain or spinal computer interface trials are currently underway.
Musk – who also owns Twitter and is the CEO of Tesla and SpaceX – said last December his team was in the process of asking regulators to allow them to test the Neuralink device.
About the size of a large coin, the device will be implanted in the skull, with ultra-thin wires going straight into the brain. Musk said the first two uses in humans are to try to restore vision and to help people with little or no ability to operate their muscles quickly use digital devices quickly. He also said he envisions signals being relayed from the brain to Neuralink devices in the spinal cord of someone with a broken neck.
After Musk gave a presentation about the device late last year, Rajesh Rao, co-director of the Center for Neurotechnology at the University of Washington, said he doesn’t think Neuralink can match other teams in terms of achievements at the brain-computer interface ahead as far as the hardware in the devices is concerned, is “right in front”.
It’s unclear how well this device or similar interfaces will ultimately work, or how secure they might be. Neuralink’s interface is currently considered “testing equipment” and clinical studies are designed to collect safety and efficacy data.
In its tweet this week, Neuralink said it was not yet recruiting participants for the study and would provide more information soon.
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