Synchron was the “tiny Neuralink rival” that won the 2021 milestone: the U.S. Food and Drug Administration authorized its Stentrode implant for a human clinical investigation before Neuralink had begun human studies. This was an investigational device exemption (IDE), not permission to sell the implant or proof that it was safe and effective for routine use.
Which company beat Neuralink to human testing?
Australian-founded neurotechnology startup Synchron received FDA authorization in July 2021 to begin a clinical study of its brain-computer interface, the Stentrode. Neuralink was then testing in animals and had not started human studies, putting Synchron ahead for this specific regulatory milestone. The timing did not establish that Stentrode was safer, more effective, or closer to commercial use. CNBC’s July 2021 report covered the authorization.
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What is Synchron’s Stentrode?
Stentrode is an investigational neural implant designed to detect brain signals associated with a person’s intention to move and translate them into commands for external technology. The planned study focused on people with paralysis, with potential uses such as operating communication devices or robotic limbs. The study was intended to investigate safety and performance; it did not establish that the device could reliably help every person with paralysis or deliver a therapeutic benefit.
How does its access route differ from Neuralink’s?
Synchron’s approach was described as delivering the Stentrode through the jugular vein so it could sit in a blood vessel near the brain. The 2021 comparison described Neuralink’s system as requiring wires to pass through the skull into brain tissue. A vascular route avoids that skull-penetrating approach, which is why Stentrode was characterized as less invasive. That description is comparative, not a finding that the procedure is risk-free or that the two systems have equivalent performance.
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For a meaningful comparison between brain-computer interfaces, consider the access route, the kind of human or animal evidence available, the regulatory stage, and the intended use. The 2021 milestone was about authorization to investigate a device—not a head-to-head clinical comparison.
What did the FDA authorization allow?
An investigational device exemption permits a clinical investigation under regulatory oversight. It is not FDA marketing authorization, commercial approval, or a recommendation for routine patient care. Synchron said the initial study would include six volunteers with paralysis. CEO Thomas Oxley said, “The approval of this [investigational device exemption] reflects years of safety testing performed in conjunction with FDA.” That statement describes the company’s view of the authorization; the planned study still needed to assess the implant in people.
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- What it allowed: researchers to begin the authorized clinical investigation.
- What it did not establish: proven effectiveness, long-term safety, suitability for every patient, or availability for consumers.
How does the 2021 milestone fit later brain-implant trials?
The 2021 Synchron authorization should not be confused with later human-testing efforts by other companies. In 2025, WIRED reported that Paradromics briefly inserted and removed its Connexus implant during epilepsy surgery—a different approach and a separate event, not a long-term implant trial comparable to Synchron’s planned study. WIRED’s 2025 report describes that procedure.
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