

Neuralink · od Erste Human-Implantation im Januar 2024 (PRIME Study); kein kommerzielles Release-Datum, Gerät ist investigational. · 3× · naposledy 21. 9. 2026
The N1 Implant is Neuralink's intracortical brain-computer interface (BCI) that records neural activity via 1,024 electrodes distributed across 64 ultra-thin, flexible threads. The device is surgically placed under the scalp by the R1 surgical robot, is cosmetically invisible, communicates wirelessly, and is inductively recharged via the N1 Charger. It is currently used only within clinical trials (including PRIME, CONVOY, CAN-PRIME, VOICE) and is not commercially available; the FDA has granted Breakthrough Device Designation for its speech-restoration application, among others.
Vlastnosti
| Compliance/Certification | FDA Investigational Device Exemption (May 2023); FDA Breakthrough Device Designation for speech restoration; Health Canada approval for CAN-PRIME |
| Deployment Model | Surgically implanted, cosmetically invisible device under the scalp, deployed only within investigational clinical trials (PRIME, CONVOY, CAN-PRIME, GB-PRIME, VOICE) |
| Use Case Scope | Helping people with paralysis/ALS control external devices (cursor, robotic arm) and restore speech through thought |
| Integrations | N1 Charger (inductive charging), Neuralink Application (decoding), R1 Robot (surgical implantation), investigational assistive robotic arm (CONVOY Study) |
| Platform | Intracortical BCI implant with 1,024 electrodes across 64 flexible threads, wireless data transmission to Neuralink Application |
| Price | No official consumer list price; device is investigational and not sold commercially, access only via clinical trials |
| Release Date | First human implantation in January 2024 as part of the PRIME Study |