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BCI · N1 · R1 · PRIME · VOICE · Blindsight

Neuralink

Last updated 22 Aug 2026 · Europe/Zurich

Status

Multi-country early feasibility for a fully implantable wireless BCI. Devices remain investigational. 21 “Neuralnauts” as of 28 Jan 2026. Zero serious device-related AEs as of that company update. Anything above 21 is unconfirmed until Neuralink or a hospital publishes it.

Next

Blindsight first-in-human — Musk said 2026; still “upcoming,” no NCT, no implant. US PRIME primary completion was 1 Jun 2026; no public results dump yet. UAE-PRIME primary completion est. Nov 2026. VOICE open since Oct 2025 (n≈6).

Competition

Synchron: COMMAND done, pivotal next — less invasive, later-stage safety package. Paradromics first long-term human June 2026. Neuralink higher bandwidth, still EFS. First commercial motor/communication BCI approval commonly estimated 2028–2030.

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Neuralink

Last updated: 2026-08-22

Status

Neuralink is in multi-country early feasibility for a fully implantable wireless BCI (N1 Implant + R1 surgical robot). Devices remain investigational — not FDA-approved for commercial sale. The company reports zero serious device-related adverse events as of its 28 January 2026 “Two Years of Telepathy” update.

Official implant / participant count: 21 “Neuralnauts” enrolled in trials worldwide as of 28 January 2026 (Neuralink blog). Timeline in that post: 1 implant H1 2024, 2 in H2 2024, 4 in H1 2025, 13 in H2 2025. First human: Noland Arbaugh, January 2024 (Telepathy / PRIME).

Later counts are not on neuralink.com. Secondary BCI press (Inside BCI, 4 July 2026) claimed a 26-participant disclosed cohort after a 20 May 2026 Canadian ALS transdural case. Treat anything above 21 as unconfirmed until Neuralink or a hospital publishes it.

Implant and robot

  • N1 (Telepathy / Link): skull-mounted, wireless, rechargeable. >1,000 electrodes on ultra-thin threads (UCLH / Neuralink materials). Company plans (Jan 2026) to raise electrode count from 1,000 to 3,000 and add mechanical features for thread retention.
  • R1 Robot: robotic thread inserter. Neuralink is investigating transdural insertion (through dura, less invasive). Secondary reporting of a first transdural human case in Canada (May 2026) is not on the company blog.
  • First-generation thread retraction (Noland) led to surgical/post-op changes; company says signal quality improved in 18 of the subsequent 20 participants (Jan 2026).
  • Quantified BCI performance: able-bodied mouse ~8–10 bits/s; multiple participants reached or exceeded that (Nick >10 BPS in week one). Imagined-finger typing up to ~40 WPM. Target for VOICE: conversational ~140 WPM.

Indications and trials

Study NCT Status (registry) Sites / notes
PRIME (US parent) NCT06429735 Recruiting (last verified Jan 2026) Barrow Neurological Institute (Phoenix; PI Francisco Ponce, MD); University of Miami / Miami Project (PI Jonathan Jagid, MD). Estimated enrollment 15. Start 9 Jan 2024. Primary completion est. 1 June 2026; study completion est. 1 Jan 2031. Quadriplegia from SCI or ALS ≥1 year.
CAN-PRIME NCT06700304 Recruiting UHN Toronto Western. PI Dr. Andres Lozano. Est. enrollment 6. Start 20 Nov 2024. UHN: first surgeries outside the US 27 Aug and 3 Sep 2025 (cervical SCI).
GB-PRIME NCT07127172 Recruiting UCLH National Hospital for Neurology and Neurosurgery (lead) + Newcastle. 7 participants, surgeries Oct–Dec 2025 (UCLH, 29 Jan 2026). MHRA/HRA/REC approved. UCLH note: GB-PRIME does not include robotic-arm control.
UAE-PRIME NCT06992596 Recruiting Cleveland Clinic Abu Dhabi. Est. enrollment 10. Start 9 May 2025; primary completion est. Nov 2026; completion est. Nov 2027. SCI, stroke, or ALS/progressive disease.
VOICE NCT07224256 Recruiting UT Southwestern, Dallas. Est. enrollment 6. Start 3 Oct 2025; primary completion est. Oct 2028. Speech restoration (ALS, PLS, stroke, SCI) with impaired upper limb. Ages 22–75. Endpoint includes monthly max correct words per minute.
Blindsight Upcoming on neuralink.com/trials Visual cortex stimulation. FDA Breakthrough Device designation (Sep 2024). No ClinicalTrials.gov listing and no reported human implant as of 22 Aug 2026. Musk has said first implant “later this year” (May 2026 remarks) — ambition, not a completed case.
CONVOY Named in Series E post (Jun 2025) Robotic-arm / physical-device control path. Limited public registry detail.

Patient registry: https://neuralink.com/trials/ (worldwide). Contact: clinical-team-ct@neuralink.com / (877) 398-4465.

Business

  • Series E: $650 million, announced 2 June 2025. Named participants: ARK, DFJ Growth, Founders Fund, G42, Human Capital, Lightspeed, QIA, Sequoia, Thrive, Valor, Vy Capital. At announcement: 5 pioneers; trials in US, Canada, UAE (UK GB-PRIME came later).
  • Valuation: Semafor/SiliconANGLE reported ~$9B pre-money. Not stated on neuralink.com. 2026 secondary-market prints ($29–42B) are unconfirmed.
  • Revenue: no product revenue disclosed. LinkedIn-scraped $20–30M figures are not a company filing.
  • No PMA / commercial reimbursement yet. Waiting-list size “>10,000” is secondary.

Next milestone

Window Item Confidence
2H 2026 Blindsight first-in-human — company/Musk intent; no IDE listing found Uncertain
2026 US PRIME primary-completion date on ClinicalTrials.gov is 1 June 2026; registry not obviously updated since January — watch for a results/amendment dump Date is on registry; results not public
2026–27 VOICE first speech-decoding implants at UTSW (trial open since Oct 2025; enrollment 6) Medium
Coming months (per Jan 2026 blog) 1,000→3,000 electrodes; thread-retention mechanics; transdural technique Company-stated R&D
~12 months from Jan 2026 GB-PRIME peer-reviewed paper (secondary expectation, not a UCLH commitment) Low
2027–31 Long-term follow-up across PRIME family (completion dates 2027–2031) Registry

Competition

No motor/communication BCI has a full FDA PMA as of August 2026 (industry trackers). Neuralink is the largest single-sponsor wireless intracortical program in the West; academic Utah-array work is older but fragmented.

Company Approach 2026 status (sourced)
Synchron Endovascular Stentrode (jugular → motor-cortex vessel). Lower invasiveness, lower channel count. COMMAND EFS (NCT05035823): 6 implanted, primary completion 19 Sep 2024, study completion est. Sep 2026, status active-not-recruiting. Positive 12-month safety (Business Wire, Sep 2024). Pivotal-trial prep widely reported; not yet a PMA.
Precision Neuroscience Layer 7 cortical surface array; 510(k) short-term use path. Industry trackers cite 510(k) clearance for limited/intraoperative use and dozens of mappings. Not a chronic wireless implant at Neuralink scale. Confirm on precisionneuro.co before citing a patient N.
Blackrock Neurotech Utah array / NeuroPort; decades of BrainGate academia. Highest cumulative research implant count (often cited >40) across PIs, not one company trial. Wired percutaneous connectors vs Neuralink’s fully implanted wireless.
Paradromics Connexus high-data-rate microelectrode array + chest transceiver. Company news 17 June 2026: first long-term human implant in FDA Connect-One EFS at University of Michigan Health (speech + computer control; motor neuron disease). Sites also UC Davis, MGH. Builds on a 2025 temporary epilepsy-research placement.
China (NeuroXess / Neuracle NEO) Flexible / confirmatory cohorts Secondary tallies (54 / 36) — different regulators (NMPA). Not a US/EU competitor for FDA PMA.

Business read: Synchron is the regulatory tortoise (minimally invasive, COMMAND done, pivotal next). Neuralink is the bandwidth/scale hare (1k+ channels, surgical robot, 4 countries, speech + vision pipeline) but still EFS. Paradromics just entered humans. First commercial motor/communication BCI approval is still commonly estimated 2028–2030.

Key people

Person Role
Elon Musk Co-founder / chairman
DJ Seo Co-founder, President (and COO on LinkedIn)
Francisco Ponce, MD US PRIME PI, Barrow
Jonathan Jagid, MD US PRIME PI, University of Miami
Andres Lozano, MD CAN-PRIME PI, UHN
Harith Akram / William Muirhead GB-PRIME chief investigator / UCLH PI (UCLH 29 Jan 2026)
Matthew MacDougall Long-time Neuralink Head of Neurosurgery — confirm if still current; not in 2026 trial posts

Sources

Primary - https://neuralink.com/updates/two-years-of-telepathy/ (28 Jan 2026) — 21 participants, 1k→3k electrodes, transdural R&D, 0 serious device AEs, VOICE, 40 WPM / 140 WPM targets - https://neuralink.com/trials/ — Telepathy active, VOICE active, Blindsight upcoming - https://neuralink.com/updates/neuralink-raises-650m-series-e/ (2 Jun 2025) - https://neuralink.com/pdfs/PRIME-Study-Brochure.pdf - ClinicalTrials.gov / mirrors: NCT06429735, NCT06700304, NCT07127172, NCT06992596, NCT07224256, NCT05035823 (Synchron) - UCLH: https://www.uclh.nhs.uk/news/seven-gb-prime-patients-now-participating-neuralink-trial (29 Jan 2026) - UHN/newswire: first Canadian surgeries 27 Aug & 3 Sep 2025 — https://www.newswire.ca/news-releases/uhn-performs-first-neuralink-implant-surgeries-outside-the-u-s--870318530.html - Paradromics: https://paradromics.com/news/paradromics-completes-first-human-brain-computer-interface-bci-implantation/ (17 Jun 2026) - Synchron COMMAND: https://www.businesswire.com/news/home/20240930433219/en/Synchron-Announces-Positive-Results-from-U.S.-COMMAND-Study-of-Endovascular-Brain-Computer-Interface

Secondary (flagged in text) - Inside BCI 10 Apr 2026 (20-implant milestone) and 4 Jul 2026 (transdural / N=26 claim) - SiliconANGLE / Reuters / Semafor on $9B pre-money - bciintel.com FDA tracker (enrollment tables — cross-check, not a registry)