Digging In

Tiny Neuralink Rival Wins Race for Approval To Test Brain Implant in Humans

"The approval of this [investigational device exemption] reflects years of safety testing performed in conjunction with FDA."

Jul 28 / Dan Robitzski
Synchron/Futurism
Image by Synchron/Futurism

On Wednesday, a small neurotech startup called Synchron was granted regulatory approval by the FDA to start testing out its brain implant on human volunteers.

The news puts the upstart Synchron way ahead of rival companies in the industry, including Elon Musk’s lavishly-funded Neuralink, which has yet to make the jump from experimenting on animals to humans.

With that go-ahead, Synchron announced that it plans to begin preliminary human studies later this year on what it calls the Stentrode, Insider reports. The Stentrode is a neural implant that taps into the brain through the jugular, and the goal is to use it like an implanted brain-computer interface to grant six volunteers with paralysis control over external devices.

“The approval of this [investigational device exemption] reflects years of safety testing performed in conjunction with FDA,” Synchron CEO Thomas Oxley said in the company announcement. “We have worked together to pave a pathway forward, towards the first commercial approval for a permanently implanted BCI for the treatment of paralysis. We are thrilled to finally be launching a US clinical trial this year.”

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When Oxley first described the Stentrode to Futurism back in 2019, he described it as a machine that would allow people with paralysis to control all sorts of machinery, from communication devices to robotic limbs or exoskeletons.

“What’s behind paralysis? The intention to move,” he said at the time. “So we’re digitizing intention. Ultimately, if those signals are really fast, those patients or people are now controlling technologies with a level of superiority may not be possible with a regular human body.”

Aside from beating Neuralink — which CEO Elon Musk previously claimed would have moved on to human research by last year — to the punch, Synchron also offers a far less invasive approach to neural implants. Neuralink’s implant includes wires that get drilled through the user’s skull, while the Stentrode can rest outside of the skull altogether.

The race to develop and test neural implants is heating up even beyond Synchron and Neuralink. Last week, Bloomberg reported that the neurotech company Paradromics raised $20 million to further develop and refine its own neural implant, which it claims will grant people with paralysis the ability to move and communicate via brain-computer interface.

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Paradromics has also lagged behind Synchron in the regulatory pathway, but it claims it will be applying for permission to test on humans as soon as next year.


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