Yes. Reuters reported that the FDA rejected Neuralink’s application to begin testing its brain implant in people in 2022, citing safety questions. That was a setback to a proposed clinical trial—not a decision on whether the implant could eventually be sold.
What safety issues were reported?
Reuters reported in March 2023, citing seven current and former Neuralink employees, that the FDA returned the application with dozens of issues to address. The agency’s rejection letter has not been made public, so the full deficiency list and the FDA’s exact wording cannot be independently reviewed.
According to those employee accounts, the reported concerns included:
- The implant’s lithium battery: questions about the risks associated with a battery implanted in the brain.
- Electrode-wire migration: the possibility that the implant’s tiny wires could move from their intended position.
- Removal: whether the device could be taken out without damaging brain tissue.
These are concerns attributed to Reuters’ sources, not quotations from a publicly available FDA letter.
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What did the rejection mean?
The application concerned permission to investigate the device in a human clinical study. It was not a final commercial-approval application, and the reported rejection did not establish that Neuralink could never test or market a device.
The FDA explains that an investigational device exemption, or IDE, allows an investigational device to be used in a clinical study to collect safety and effectiveness data. For a significant-risk device study, FDA approval of the IDE and approval by an institutional review board are required, alongside protections for participants. An IDE is a route to research use; it is not marketing clearance or proof that a device is safe and effective for general use.
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What happened after the reported rejection?
| When | What happened |
|---|---|
| Early 2022 | Neuralink reportedly sought FDA permission to begin human testing. Reuters’ employee sources said the application was rejected and returned with issues to address. |
| March 2–3, 2023 | Reuters published its account of the earlier rejection. |
| May 2023 | Neuralink announced that the FDA had authorized its first-in-human clinical study. |
| January 2024 | News reports described the first human implant after the company had obtained authorization to proceed with a study. |
The later authorization shows that the earlier rejection was not the end of the regulatory process. Neuralink announced the authorization; that announcement should not be treated as independent confirmation of every study detail.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Is Neuralink approved, or is it still experimental?
The device described in Neuralink’s PRIME study materials is an investigational N1 brain implant and surgical system. The brochure calls PRIME an investigational medical-device clinical trial for the company’s first brain-computer interface. Authorization to conduct that study permits research in the trial setting; it does not make the implant an approved consumer product.
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In short, the reported 2022 decision was about an application to start human testing. Neuralink later announced authorization for a first-in-human study, but the implant remains investigational in the context described by those study materials.
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