Neuralink’s Human Brain-Chip Trial Gets Green Light As FDA Reverses Decision
By Alexa Heah, 31 May 2023
For those who aren’t caught up on Elon Musk’s Neuralink venture, here’s a summary. Back in December 2022, the CEO promised the company was on its way to having a brain chip implanted in a human “in about six months.”
That plan seemed to have hit a snag in March this year when the US Food and Drug Administration (FDA) rejected the firm’s application to test its technology on human subjects, citing safety concerns.
Now, however, it appears the agency may have reneged on its previous ruling, with Neuralink’s official Twitter account recently announcing that it received official approval to conduct its first-ever human clinical study.
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study! This is a result of the incredible work by the Neuralink team in close collaboration with the FDA,” the tweet read.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!— Neuralink (@neuralink) May 25, 2023
This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…
“And represents an important first step that will one day allow our technology to help many people,” it continued. The FDA has since confirmed Neuralink’s statement to publications, including Mashable.
An FDA spokesperson explained that the company’s implant—dubbed the R1 robot—will begin undergoing human clinical trials soon. The robot works as a “surgeon” to place the implantable brain chains in a subject’s brain.
According to the firm, these implants could one day allow patients to control computers with their brains, restore vision to blind people, or allow those with mobility issues to walk again.
Will this finally be the time when Neuralink experiments with its first human patients? Or will the world have to wait even longer to see if the technology will come good? You might soon find out.
Our surgical robot uses advanced imaging systems to detect the brain and insert threads away from blood vessels. Here, you can see everything the robot sees while we test the accuracy of each of the robot’s high-precision cameras ð #techtuesday pic.twitter.com/c5rklTp2m4— Neuralink (@neuralink) May 23, 2023
We use dynamic mechanical analyzers to fatigue test our threads and identify changes in their mechanical properties over time. It’s hard to spot, but here you can see us testing a thread by emulating the brain motion due to our heartbeat at 1Hz and an accelerated test at 10Hz ð«… pic.twitter.com/lN2P4Ymuns— Neuralink (@neuralink) May 17, 2023
We test the thermal performance of our implants to ensure safety and improve efficiency. Here, we are taking infrared images to detect hotspots on the bottom surface of an implant while charging with the charger coil in different positions. Stay cool ð #techtuesday pic.twitter.com/nrEDMscyCO— Neuralink (@neuralink) May 10, 2023
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