Synchron was first: in July 2021, the FDA authorized the company to begin a human study of its Stentrode brain-computer interface. The authorization was an investigational device exemption (IDE), not approval to sell the implant or offer it as routine care. The planned study would enroll six people with paralysis and investigate whether brain signals could control external devices.
What company beat Neuralink to human brain-implant trials?
Synchron, an Australian-founded neurotechnology company, received FDA authorization for the Stentrode study in July 2021. At that point, Neuralink was testing its technology in animals and had not begun human studies, putting Synchron ahead in this specific regulatory milestone. The comparison concerns timing of authorization to start a trial; it does not show that Stentrode was safer, more effective, or closer to commercial use. The 2021 report
What is Synchron’s Stentrode?
Stentrode is an investigational brain-computer interface implant designed to detect signals associated with a person’s intended movements. Researchers planned to study whether those signals could be used to operate external technology, including communication devices or robotic limbs, for people with paralysis. The study was intended to examine safety and performance; it did not establish that the system would work for every participant or provide a proven treatment.
How does the implant reach the brain?
Stentrode is delivered through the jugular vein and positioned in a blood vessel near the brain. That vascular route differs from the Neuralink approach described at the time, which involved wires passing through the skull into brain tissue. The route was presented as less invasive, but “less invasive” is a comparison of access methods—not a claim that implantation has no risks or that the device is proven safe for long-term use. The 2021 report
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Did Synchron get FDA approval to sell a brain implant?
No. The FDA issued an investigational device exemption, or IDE, allowing a clinical investigation to proceed. An IDE is not marketing authorization, approval for routine medical care, or evidence that a device is effective. Synchron 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 basis for the investigation authorization, not a commercial clearance.
What the planned study could—and could not—show
- Planned participants: Six volunteers with paralysis.
- Study aim: Investigate safety and performance while participants use brain signals to control external devices.
- Not established by authorization: Long-term safety, benefit for all people with paralysis, effectiveness as a treatment, routine-care eligibility, or consumer availability.
How should Synchron be compared with later brain-computer interface companies?
The 2021 Synchron milestone should not be merged with later human-testing events. In 2025, WIRED reported that Paradromics briefly inserted and removed its Connexus implant during epilepsy surgery—a different testing route and context from Synchron’s planned study of a vascular implant. WIRED’s 2025 report
“Who won” depends on what is being compared. A meaningful comparison distinguishes the implant’s access route, the kind and duration of human exposure, the regulatory stage, intended use, and published evidence on safety, signal quality, and durability. The reported milestones do not provide head-to-head evidence that one company’s system performs better than another’s.
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