Neuralink N1 Device and Regulatory Status Record

Neuralink N1 Device and Regulatory Status Record

The N1 Implant is Neuralink's investigational implanted brain-computer interface. The PRIME registry record describes a skull-mounted, wireless, rechargeable implant connected to electrode threads placed by the R1 Robot. The system records neural activity associated with movement intention for external-device control.

Neuralink's device-control trial page describes PRIME and CONVOY as active research paths. The page calls N1 investigational. Neuralink's PRIME recruitment announcement says the study operates under an FDA investigational device exemption.

FDA's IDE overview explains that an IDE permits an investigational device to be used in a clinical study to collect safety and effectiveness data. It is not clearance or marketing approval.

Sponsor updates describe computer control, games, design software, use duration, thread retraction, software changes, and additional investigational work. Those reports can establish what Neuralink and named participants said. They do not establish general safety, effectiveness, durability, eligibility, or benefit.

The public profile must keep device identity, intended study use, regulatory state, sponsor-reported experience, and results status separate. It should not describe N1 as a consumer product, ordinary treatment, restored movement, or approved route to controlling a robot.