## EN: Neuralink — What It Is, How It Works, Current Human Trials, Benefits, Ris…
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## EN: Neuralink — What It Is, How It Works, Current Human Trials, Benefits, Risks, and Future Directions
## KR: 뉴럴링크 — 무엇이며 어떻게 작동하고, 인간 임상 현황·효과·위험·미래는 무엇인가
[](https://neuralink.com/updates/prime-study-progress-update/?utm_source=chatgpt.com)
---
## English (EN)
### 1) What Neuralink is (in plain terms)
**Neuralink** is a neurotechnology company developing an **implantable brain–computer interface (BCI)**: a medical device intended to **record brain signals** and translate them into **computer control** (and eventually, in Neuralink’s long-term vision, possibly also write signals back into the nervous system). Neuralink presents its near-term clinical goal as restoring autonomy for people with severe motor impairment by enabling hands-free control of computers and assistive devices. ([Neuralink][1])
### 2) The system components: Implant + robot + external devices
Neuralink’s current human-trial platform is typically described as:
* **N1 Implant**: the implanted device that records neural activity. ([Neuralink][2])
* **Electrode “threads”**: very thin flexible leads with many electrodes; public reporting describes **“more than 1,000 electrodes”** across “several dozen threads.” ([Fierce Biotech][3])
* **R1 Robot**: a surgical robot designed to place the threads precisely into targeted brain regions. ([Fierce Biotech][3])
* **External charging / app interface**: an external system to power/charge and a software stack to decode signals into actions (cursor control, clicks, etc.). Neuralink has published diagrams describing the N1 implant and a charger/application workflow. ([Neuralink][4])
### 3) How it works: from neurons to cursor control
A simplified pipeline:
1. **Neural activity** is recorded by electrodes placed in/near the target cortical area (often discussed publicly as motor cortex for movement intent).
2. The implant **digitizes and transmits** signals to external computing. ([Neuralink][4])
3. Machine-learning decoders translate signal patterns into **control outputs**, such as moving a cursor, selecting UI elements, and (in broader BCI research) controlling assistive devices.
Neuralink markets its initial capability as **“Telepathy”**—hands-free computer control via thought—within its clinical-trial context. ([Neuralink][5])
### 4) Regulatory and clinical-trial status (what is officially known)
**FDA IDE (Investigational Device Exemption):** Neuralink stated its first-in-human study (PRIME) operates under an FDA IDE granted in **May 2023**; this is also reported by major outlets. ([Neuralink][6])
**PRIME Study:** Neuralink’s public trial page identifies PRIME and links to **ClinicalTrials.gov ID NCT06429735**, describing investigation of the N1 Implant and R1 Robot for people with limited hand function due to conditions such as spinal cord injury or ALS (exact inclusion/exclusion and endpoints are documented on the registry and Neuralink’s trial pages). ([Neuralink][2])
**Additional related trials/registrations:** Neuralink-associated studies and regional feasibility studies appear on ClinicalTrials.gov (e.g., entries describing feasibility and device-control extensions). ([ClinicalTrials][7])
**Canada launch:** Neuralink posted an update about opening a Canadian feasibility study (CAN-PRIME) for eligible Canadian residents with limited/no ability to use both hands due to ALS or spinal cord injury. ([Neuralink][8])
### 5) Human-implant milestones and reported outcomes (high-level, with important caveats)
* Neuralink reports its **first human implantation** occurred in **January 2024**. ([Neuralink][4])
* Reuters reported that the first patient could **control a computer mouse/cursor with thought**, per statements from Elon Musk. ([Reuters][9])
* Neuralink later published “A Year of Telepathy” describing progress in its first participant’s use and experience. ([Neuralink][5])
* Independent reporting has also described challenges such as **some implanted threads detaching/retracting**, affecting performance, with function partly recovered through software/decoder updates. (This specific issue is described in long-form reporting and interviews; treat as participant-level reporting, not generalized performance data.) ([가디언][10])
**Critical caveat:** These are early feasibility-stage signals. They do not yet establish long-term safety, durability, or generalized effectiveness across broader populations.
### 6) “Breakthrough Device” designation (what it means, and what it does not)
Reuters reported that Neuralink received an FDA **“Breakthrough Device” designation** for a technology aimed at restoring communication for people with severe speech impairment. ([Reuters][11])
This designation can **expedite development and review interactions**, but it is **not the same as marketing approval** and does not by itself prove safety/effectiveness.
### 7) Benefits (why this is compelling)
If the technology proves safe and durable, plausible benefits include:
* **Restored digital autonomy** (typing, browsing, communication, work) for people with quadriplegia or severe motor impairment. ([Neuralink][1])
* Potential control of **assistive devices** (e.g., computer interfaces, possibly robotic devices), which is explicitly explored in trial structures. ([ClinicalTrials][7])
* Reduced dependence on eye-tracking or switch-based systems for some users, depending on individual capability and BCI performance.
### 8) Risks and limitations (technical + medical + operational)
**Surgical/medical risks (general for implanted neurodevices):**
* Infection, bleeding, seizures, device-related inflammation, neurological injury risk, and anesthesia risk (severity varies; managed under clinical protocols).
**Device/engineering risks:**
* **Signal degradation** over time (scar tissue response, micro-motion, electrode failure) and mechanical issues like **thread migration/retraction** reported in early coverage. ([가디언][10])
* Battery/charging constraints, telemetry reliability, and hardware longevity.
**Operational risks:**
* User training burden, calibration time, and variable daily performance.
**Cybersecurity & privacy:**
* BCIs raise unusually sensitive data concerns: neural signal data, intent inference, and device integrity/security (a major ethical and engineering domain in the field).
### 9) Ethical and governance issues that follow “civilization-scale” adoption
If implant BCIs ever move beyond niche clinical populations, societies will face:
* **Informed consent** standards for invasive elective enhancement.
* **Equity and access** (who gets high-function augmentation and who doesn’t).
* **Data rights** (who owns neural data, how it can be used, and what constitutes “neural privacy”).
* **Regulatory oversight** (post-market surveillance, adverse event reporting, long-term registries).
### 10) Where Neuralink sits in the broader BCI landscape
Neuralink is highly visible, but BCIs are not new; multiple academic and industry groups have pursued implanted and noninvasive interfaces for years. A STAT analysis noted Neuralink’s first-in-human timeline arrived after earlier neurotech efforts, framing it as entering a mature field rather than inventing it from scratch. ([STAT][12])
Neuralink’s distinctive bets are commonly described as:
* **High-channel-count flexible threads** +
* **robotic implantation** for precision/scale. ([Fierce Biotech][3])
---
## 한국어 (KR)
### 1) 뉴럴링크란 무엇인가
**뉴럴링크(Neuralink)**는 뇌에 기기를 이식해 **뇌 신호를 읽고(기록)** 이를 **컴퓨터 제어**로 바꾸는 **뇌–컴퓨터 인터페이스(BCI)**를 개발하는 회사입니다. 회사가 공개한 임상 목표는 중증 운동장애(사지마비 등) 환자가 생각만으로 디지털 기기·보조기기를 조작하도록 **자율성을 회복**시키는 것입니다. ([Neuralink][1])
### 2) 시스템 구성(이식체 + 로봇 + 외부 장치)
* **N1 이식체(Implant)**: 뇌 신호를 기록하는 이식 장치 ([Neuralink][2])
* **전극 “실(threads)”**: 매우 얇고 유연한 다수 전극. 보도/설명에서는 “1,000개 이상 전극”이 “수십 가닥 실”에 배치된 형태로 설명됩니다. ([Fierce Biotech][3])
* **R1 로봇**: 전극 실을 목표 뇌 영역에 정밀하게 삽입하기 위한 수술 로봇 ([Fierce Biotech][3])
* **충전기/앱/디코더**: 무선 충전과 소프트웨어(디코딩)가 결합되어 커서 이동·클릭 등 입력으로 변환됩니다. 뉴럴링크는 N1/충전기/앱 흐름을 도식으로 공개했습니다. ([Neuralink][4])
### 3) 작동 원리(개략)
1. 목표 뇌 영역의 신경활동을 전극이 기록
2. 이식체가 신호를 처리·전송 ([Neuralink][4])
3. 소프트웨어/AI 디코더가 신호 패턴을 입력(커서·클릭 등)으로 변환
뉴럴링크는 초기 기능을 **“Telepathy”**(생각으로 컴퓨터 제어)로 소개합니다. ([Neuralink][5])
### 4) 규제·임상 현황(공식적으로 확인 가능한 범위)
* 뉴럴링크는 **2023년 5월 FDA IDE(임상시험용 의료기기 허가 프레임)**를 받아 PRIME 연구를 진행한다고 밝혔고, 주요 언론도 이를 보도했습니다. ([Neuralink][6])
* PRIME 연구는 뉴럴링크 공개 페이지에서 **ClinicalTrials.gov ID: NCT06429735**로 연결되며, N1 이식체와 R1 로봇의 안전성과 기능을 평가하는 구조로 안내됩니다. ([Neuralink][2])
* 관련 확장 연구/지역 연구(보조기기 제어, 국가별 feasibility 연구 등)가 ClinicalTrials.gov에 다수 등록되어 있습니다. ([ClinicalTrials][7])
* 캐나다에서는 CAN-PRIME 개시를 공식 업데이트로 공지했습니다. ([Neuralink][8])
### 5) 인간 이식 성과(초기 단계)
* 회사는 **2024년 1월 첫 인간 이식**을 수행했다고 공개했습니다. ([Neuralink][4])
* 로이터는 첫 환자가 생각만으로 **컴퓨터 커서/마우스 제어**가 가능해 보인다고 전했습니다(머스크 발언 인용). ([Reuters][9])
* 이후 회사는 “A Year of Telepathy” 업데이트로 1년 경과 경험을 공유했습니다. ([Neuralink][5])
* 독립 보도에서는 일부 전극 실의 **이탈/후퇴로 성능 저하**가 있었고, 소프트웨어 조정으로 일부 기능이 회복됐다는 내용이 언급됩니다(사례 기반 보도이므로 일반화는 금물). ([가디언][10])
### 6) Breakthrough Device 지정
로이터는 뉴럴링크가 중증 언어장애 환자의 의사소통 회복을 목표로 한 기술에서 FDA **Breakthrough Device** 지정을 받았다고 보도했습니다. ([Reuters][11])
이는 심사·개발 지원을 가속할 수 있으나, **시판 허가와 동일하지 않습니다**.
### 7) 위험·한계(핵심 포인트)
* 수술/이식 일반 위험: 감염, 출혈, 신경학적 합병증, 마취 위험
* 공학적 위험: 신호 열화(조직 반응, 전극 고장), 전극 실 이동/후퇴 가능성(초기 보도 사례) ([가디언][10])
* 개인정보/보안: 신경 데이터의 민감성과 기기 보안의 중요성
* 장기 내구성: 수년 단위 성능·교체·업그레이드 정책 등은 아직 임상 데이터가 축적 중
---
## 日本語 (JA)
### 1) Neuralink とは
Neuralink は、脳内にデバイスを**埋め込み**、脳信号を**記録して**コンピュータ操作に変換する**BCI（Brain–Computer Interface）**を開発する企業です。臨床面では重度運動障害の人が“思考で”デジタル機器を操作できることを主目的として提示しています。 ([Neuralink][1])
### 2) 構成要素
* **N1 Implant**（埋込機器） ([Neuralink][2])
* 多数電極を持つ柔軟な“スレッド”（報道では 1,000+ 電極規模） ([Fierce Biotech][3])
* **R1 ロボット**（精密埋込のための手術ロボット） ([Fierce Biotech][3])
* 充電・アプリ・デコーダ（N1/充電/アプリの図示あり） ([Neuralink][4])
### 3) 規制・試験
* **2023年5月にFDA IDE**で初のヒト試験（PRIME）を進めると会社が説明、報道もあり。 ([Neuralink][6])
* PRIME は **NCT06429735** として案内されています。 ([Neuralink][2])
### 4) 進捗（初期）
* 2024年1月に初のヒト埋込を実施と更新。 ([Neuralink][4])
* 思考でカーソル操作が可能という報道（ロイター）。 ([Reuters][9])
* 一方でスレッドの一部が外れる/後退する課題が報じられています（個別事例）。 ([가디언][10])
---
## Español (ES)
### 1) Qué es Neuralink
Neuralink desarrolla un **BCI implantable** para **registrar señales cerebrales** y convertirlas en **control de ordenador** (y, a largo plazo, aspira a interfaces más generales). Su foco clínico inmediato es restaurar autonomía a personas con discapacidad motora severa. ([Neuralink][1])
### 2) Componentes
* **Implante N1** + **hilos con electrodos** (se ha descrito >1.000 electrodos) ([Fierce Biotech][3])
* **Robot quirúrgico R1** para implantación precisa ([Fierce Biotech][3])
* Sistema de carga y software (diagrama publicado por Neuralink) ([Neuralink][4])
### 3) Ensayos y avances
* Ensayo bajo **IDE de la FDA** (mayo 2023) y PRIME como estudio de primera vez en humanos. ([Neuralink][6])
* PRIME vinculado a **NCT06429735**. ([Neuralink][2])
* Primer implante humano en enero 2024; control de cursor reportado por Reuters. ([Neuralink][4])
* Designación **Breakthrough Device** para tecnología de restauración de comunicación, según Reuters. ([Reuters][11])
---
## Français (FR)
### 1) Définition
Neuralink développe une **interface cerveau–ordinateur (BCI) implantable** destinée à **enregistrer l’activité neuronale** et à la traduire en **commandes informatiques**. L’objectif clinique immédiat mis en avant est l’autonomie numérique pour des personnes avec déficits moteurs sévères. ([Neuralink][1])
### 2) Plateforme
* **Implant N1** et fils/électrodes (décrit publiquement à >1 000 électrodes) ([Fierce Biotech][3])
* **Robot R1** pour une implantation précise ([Fierce Biotech][3])
* Chaîne charge/logiciel (schéma publié) ([Neuralink][4])
### 3) Statut clinique
* Étude PRIME conduite sous **IDE de la FDA** (mai 2023), annoncé par l’entreprise et relayé par la presse. ([Neuralink][6])
* PRIME référencée comme **NCT06429735**. ([Neuralink][2])
* Premier implant humain (janvier 2024) et contrôle de curseur rapporté par Reuters. ([Neuralink][4])
* Désignation **Breakthrough Device** (FDA) pour une technologie de restauration de la communication, selon Reuters. ([Reuters][11])
---
**Note (all languages):** Neuralink devices are **investigational** in clinical trials; outcomes discussed publicly are early-stage and may not generalize. ([Neuralink][2])
[1]: https://neuralink.com/?utm_source=chatgpt.com "Neuralink — Pioneering Brain Computer Interfaces"
[2]: https://neuralink.com/trials/device-control/?utm_source=chatgpt.com "Device Control"
[3]: https://www.fiercebiotech.com/medtech/neuralink-implants-brain-computer-interface-first-human-trial-participant?utm_source=chatgpt.com "Neuralink implants brain-computer interface in first human"
[4]: https://neuralink.com/updates/prime-study-progress-update/?utm_source=chatgpt.com "PRIME Study Progress Update"
[5]: https://neuralink.com/updates/a-year-of-telepathy/?utm_source=chatgpt.com "A Year of Telepathy | Updates"
[6]: https://neuralink.com/updates/first-clinical-trial-open-for-recruitment/?utm_source=chatgpt.com "Neuralink's First-in-Human Clinical Trial is Open for ..."
[7]: https://clinicaltrials.gov/study/NCT06710626?utm_source=chatgpt.com "NCT06710626 | Control of Assistive Devices Via Brain- ..."
[8]: https://neuralink.com/updates/can-prime-study-launch/?utm_source=chatgpt.com "CAN-PRIME Study Launch | Updates"
[9]: https://www.reuters.com/business/healthcare-pharmaceuticals/neuralinks-first-human-patient-able-control-mouse-through-thinking-musk-says-2024-02-20/?utm_source=chatgpt.com "Neuralink's first human patient able to control mouse ..."
[10]: https://www.theguardian.com/science/2025/feb/08/elon-musk-chip-paralysed-man-noland-arbaugh-chip-brain-neuralink?utm_source=chatgpt.com "Elon Musk put a chip in this paralysed man's brain. Now he can move things with his mind. Should we be amazed - or terrified?"
[11]: https://www.reuters.com/business/healthcare-pharmaceuticals/neuralinks-speech-restoration-device-gets-fdas-breakthrough-tag-2025-05-01/?utm_source=chatgpt.com "Neuralink's speech restoration device gets FDA's 'breakthrough' tag"
[12]: https://www.statnews.com/2023/05/26/neuralink-fda-brain-computer-interface/?utm_source=chatgpt.com "Musk's Neuralink can now study its brain implant in humans"
## KR: 뉴럴링크 — 무엇이며 어떻게 작동하고, 인간 임상 현황·효과·위험·미래는 무엇인가
[](https://neuralink.com/updates/prime-study-progress-update/?utm_source=chatgpt.com)
---
## English (EN)
### 1) What Neuralink is (in plain terms)
**Neuralink** is a neurotechnology company developing an **implantable brain–computer interface (BCI)**: a medical device intended to **record brain signals** and translate them into **computer control** (and eventually, in Neuralink’s long-term vision, possibly also write signals back into the nervous system). Neuralink presents its near-term clinical goal as restoring autonomy for people with severe motor impairment by enabling hands-free control of computers and assistive devices. ([Neuralink][1])
### 2) The system components: Implant + robot + external devices
Neuralink’s current human-trial platform is typically described as:
* **N1 Implant**: the implanted device that records neural activity. ([Neuralink][2])
* **Electrode “threads”**: very thin flexible leads with many electrodes; public reporting describes **“more than 1,000 electrodes”** across “several dozen threads.” ([Fierce Biotech][3])
* **R1 Robot**: a surgical robot designed to place the threads precisely into targeted brain regions. ([Fierce Biotech][3])
* **External charging / app interface**: an external system to power/charge and a software stack to decode signals into actions (cursor control, clicks, etc.). Neuralink has published diagrams describing the N1 implant and a charger/application workflow. ([Neuralink][4])
### 3) How it works: from neurons to cursor control
A simplified pipeline:
1. **Neural activity** is recorded by electrodes placed in/near the target cortical area (often discussed publicly as motor cortex for movement intent).
2. The implant **digitizes and transmits** signals to external computing. ([Neuralink][4])
3. Machine-learning decoders translate signal patterns into **control outputs**, such as moving a cursor, selecting UI elements, and (in broader BCI research) controlling assistive devices.
Neuralink markets its initial capability as **“Telepathy”**—hands-free computer control via thought—within its clinical-trial context. ([Neuralink][5])
### 4) Regulatory and clinical-trial status (what is officially known)
**FDA IDE (Investigational Device Exemption):** Neuralink stated its first-in-human study (PRIME) operates under an FDA IDE granted in **May 2023**; this is also reported by major outlets. ([Neuralink][6])
**PRIME Study:** Neuralink’s public trial page identifies PRIME and links to **ClinicalTrials.gov ID NCT06429735**, describing investigation of the N1 Implant and R1 Robot for people with limited hand function due to conditions such as spinal cord injury or ALS (exact inclusion/exclusion and endpoints are documented on the registry and Neuralink’s trial pages). ([Neuralink][2])
**Additional related trials/registrations:** Neuralink-associated studies and regional feasibility studies appear on ClinicalTrials.gov (e.g., entries describing feasibility and device-control extensions). ([ClinicalTrials][7])
**Canada launch:** Neuralink posted an update about opening a Canadian feasibility study (CAN-PRIME) for eligible Canadian residents with limited/no ability to use both hands due to ALS or spinal cord injury. ([Neuralink][8])
### 5) Human-implant milestones and reported outcomes (high-level, with important caveats)
* Neuralink reports its **first human implantation** occurred in **January 2024**. ([Neuralink][4])
* Reuters reported that the first patient could **control a computer mouse/cursor with thought**, per statements from Elon Musk. ([Reuters][9])
* Neuralink later published “A Year of Telepathy” describing progress in its first participant’s use and experience. ([Neuralink][5])
* Independent reporting has also described challenges such as **some implanted threads detaching/retracting**, affecting performance, with function partly recovered through software/decoder updates. (This specific issue is described in long-form reporting and interviews; treat as participant-level reporting, not generalized performance data.) ([가디언][10])
**Critical caveat:** These are early feasibility-stage signals. They do not yet establish long-term safety, durability, or generalized effectiveness across broader populations.
### 6) “Breakthrough Device” designation (what it means, and what it does not)
Reuters reported that Neuralink received an FDA **“Breakthrough Device” designation** for a technology aimed at restoring communication for people with severe speech impairment. ([Reuters][11])
This designation can **expedite development and review interactions**, but it is **not the same as marketing approval** and does not by itself prove safety/effectiveness.
### 7) Benefits (why this is compelling)
If the technology proves safe and durable, plausible benefits include:
* **Restored digital autonomy** (typing, browsing, communication, work) for people with quadriplegia or severe motor impairment. ([Neuralink][1])
* Potential control of **assistive devices** (e.g., computer interfaces, possibly robotic devices), which is explicitly explored in trial structures. ([ClinicalTrials][7])
* Reduced dependence on eye-tracking or switch-based systems for some users, depending on individual capability and BCI performance.
### 8) Risks and limitations (technical + medical + operational)
**Surgical/medical risks (general for implanted neurodevices):**
* Infection, bleeding, seizures, device-related inflammation, neurological injury risk, and anesthesia risk (severity varies; managed under clinical protocols).
**Device/engineering risks:**
* **Signal degradation** over time (scar tissue response, micro-motion, electrode failure) and mechanical issues like **thread migration/retraction** reported in early coverage. ([가디언][10])
* Battery/charging constraints, telemetry reliability, and hardware longevity.
**Operational risks:**
* User training burden, calibration time, and variable daily performance.
**Cybersecurity & privacy:**
* BCIs raise unusually sensitive data concerns: neural signal data, intent inference, and device integrity/security (a major ethical and engineering domain in the field).
### 9) Ethical and governance issues that follow “civilization-scale” adoption
If implant BCIs ever move beyond niche clinical populations, societies will face:
* **Informed consent** standards for invasive elective enhancement.
* **Equity and access** (who gets high-function augmentation and who doesn’t).
* **Data rights** (who owns neural data, how it can be used, and what constitutes “neural privacy”).
* **Regulatory oversight** (post-market surveillance, adverse event reporting, long-term registries).
### 10) Where Neuralink sits in the broader BCI landscape
Neuralink is highly visible, but BCIs are not new; multiple academic and industry groups have pursued implanted and noninvasive interfaces for years. A STAT analysis noted Neuralink’s first-in-human timeline arrived after earlier neurotech efforts, framing it as entering a mature field rather than inventing it from scratch. ([STAT][12])
Neuralink’s distinctive bets are commonly described as:
* **High-channel-count flexible threads** +
* **robotic implantation** for precision/scale. ([Fierce Biotech][3])
---
## 한국어 (KR)
### 1) 뉴럴링크란 무엇인가
**뉴럴링크(Neuralink)**는 뇌에 기기를 이식해 **뇌 신호를 읽고(기록)** 이를 **컴퓨터 제어**로 바꾸는 **뇌–컴퓨터 인터페이스(BCI)**를 개발하는 회사입니다. 회사가 공개한 임상 목표는 중증 운동장애(사지마비 등) 환자가 생각만으로 디지털 기기·보조기기를 조작하도록 **자율성을 회복**시키는 것입니다. ([Neuralink][1])
### 2) 시스템 구성(이식체 + 로봇 + 외부 장치)
* **N1 이식체(Implant)**: 뇌 신호를 기록하는 이식 장치 ([Neuralink][2])
* **전극 “실(threads)”**: 매우 얇고 유연한 다수 전극. 보도/설명에서는 “1,000개 이상 전극”이 “수십 가닥 실”에 배치된 형태로 설명됩니다. ([Fierce Biotech][3])
* **R1 로봇**: 전극 실을 목표 뇌 영역에 정밀하게 삽입하기 위한 수술 로봇 ([Fierce Biotech][3])
* **충전기/앱/디코더**: 무선 충전과 소프트웨어(디코딩)가 결합되어 커서 이동·클릭 등 입력으로 변환됩니다. 뉴럴링크는 N1/충전기/앱 흐름을 도식으로 공개했습니다. ([Neuralink][4])
### 3) 작동 원리(개략)
1. 목표 뇌 영역의 신경활동을 전극이 기록
2. 이식체가 신호를 처리·전송 ([Neuralink][4])
3. 소프트웨어/AI 디코더가 신호 패턴을 입력(커서·클릭 등)으로 변환
뉴럴링크는 초기 기능을 **“Telepathy”**(생각으로 컴퓨터 제어)로 소개합니다. ([Neuralink][5])
### 4) 규제·임상 현황(공식적으로 확인 가능한 범위)
* 뉴럴링크는 **2023년 5월 FDA IDE(임상시험용 의료기기 허가 프레임)**를 받아 PRIME 연구를 진행한다고 밝혔고, 주요 언론도 이를 보도했습니다. ([Neuralink][6])
* PRIME 연구는 뉴럴링크 공개 페이지에서 **ClinicalTrials.gov ID: NCT06429735**로 연결되며, N1 이식체와 R1 로봇의 안전성과 기능을 평가하는 구조로 안내됩니다. ([Neuralink][2])
* 관련 확장 연구/지역 연구(보조기기 제어, 국가별 feasibility 연구 등)가 ClinicalTrials.gov에 다수 등록되어 있습니다. ([ClinicalTrials][7])
* 캐나다에서는 CAN-PRIME 개시를 공식 업데이트로 공지했습니다. ([Neuralink][8])
### 5) 인간 이식 성과(초기 단계)
* 회사는 **2024년 1월 첫 인간 이식**을 수행했다고 공개했습니다. ([Neuralink][4])
* 로이터는 첫 환자가 생각만으로 **컴퓨터 커서/마우스 제어**가 가능해 보인다고 전했습니다(머스크 발언 인용). ([Reuters][9])
* 이후 회사는 “A Year of Telepathy” 업데이트로 1년 경과 경험을 공유했습니다. ([Neuralink][5])
* 독립 보도에서는 일부 전극 실의 **이탈/후퇴로 성능 저하**가 있었고, 소프트웨어 조정으로 일부 기능이 회복됐다는 내용이 언급됩니다(사례 기반 보도이므로 일반화는 금물). ([가디언][10])
### 6) Breakthrough Device 지정
로이터는 뉴럴링크가 중증 언어장애 환자의 의사소통 회복을 목표로 한 기술에서 FDA **Breakthrough Device** 지정을 받았다고 보도했습니다. ([Reuters][11])
이는 심사·개발 지원을 가속할 수 있으나, **시판 허가와 동일하지 않습니다**.
### 7) 위험·한계(핵심 포인트)
* 수술/이식 일반 위험: 감염, 출혈, 신경학적 합병증, 마취 위험
* 공학적 위험: 신호 열화(조직 반응, 전극 고장), 전극 실 이동/후퇴 가능성(초기 보도 사례) ([가디언][10])
* 개인정보/보안: 신경 데이터의 민감성과 기기 보안의 중요성
* 장기 내구성: 수년 단위 성능·교체·업그레이드 정책 등은 아직 임상 데이터가 축적 중
---
## 日本語 (JA)
### 1) Neuralink とは
Neuralink は、脳内にデバイスを**埋め込み**、脳信号を**記録して**コンピュータ操作に変換する**BCI（Brain–Computer Interface）**を開発する企業です。臨床面では重度運動障害の人が“思考で”デジタル機器を操作できることを主目的として提示しています。 ([Neuralink][1])
### 2) 構成要素
* **N1 Implant**（埋込機器） ([Neuralink][2])
* 多数電極を持つ柔軟な“スレッド”（報道では 1,000+ 電極規模） ([Fierce Biotech][3])
* **R1 ロボット**（精密埋込のための手術ロボット） ([Fierce Biotech][3])
* 充電・アプリ・デコーダ（N1/充電/アプリの図示あり） ([Neuralink][4])
### 3) 規制・試験
* **2023年5月にFDA IDE**で初のヒト試験（PRIME）を進めると会社が説明、報道もあり。 ([Neuralink][6])
* PRIME は **NCT06429735** として案内されています。 ([Neuralink][2])
### 4) 進捗（初期）
* 2024年1月に初のヒト埋込を実施と更新。 ([Neuralink][4])
* 思考でカーソル操作が可能という報道（ロイター）。 ([Reuters][9])
* 一方でスレッドの一部が外れる/後退する課題が報じられています（個別事例）。 ([가디언][10])
---
## Español (ES)
### 1) Qué es Neuralink
Neuralink desarrolla un **BCI implantable** para **registrar señales cerebrales** y convertirlas en **control de ordenador** (y, a largo plazo, aspira a interfaces más generales). Su foco clínico inmediato es restaurar autonomía a personas con discapacidad motora severa. ([Neuralink][1])
### 2) Componentes
* **Implante N1** + **hilos con electrodos** (se ha descrito >1.000 electrodos) ([Fierce Biotech][3])
* **Robot quirúrgico R1** para implantación precisa ([Fierce Biotech][3])
* Sistema de carga y software (diagrama publicado por Neuralink) ([Neuralink][4])
### 3) Ensayos y avances
* Ensayo bajo **IDE de la FDA** (mayo 2023) y PRIME como estudio de primera vez en humanos. ([Neuralink][6])
* PRIME vinculado a **NCT06429735**. ([Neuralink][2])
* Primer implante humano en enero 2024; control de cursor reportado por Reuters. ([Neuralink][4])
* Designación **Breakthrough Device** para tecnología de restauración de comunicación, según Reuters. ([Reuters][11])
---
## Français (FR)
### 1) Définition
Neuralink développe une **interface cerveau–ordinateur (BCI) implantable** destinée à **enregistrer l’activité neuronale** et à la traduire en **commandes informatiques**. L’objectif clinique immédiat mis en avant est l’autonomie numérique pour des personnes avec déficits moteurs sévères. ([Neuralink][1])
### 2) Plateforme
* **Implant N1** et fils/électrodes (décrit publiquement à >1 000 électrodes) ([Fierce Biotech][3])
* **Robot R1** pour une implantation précise ([Fierce Biotech][3])
* Chaîne charge/logiciel (schéma publié) ([Neuralink][4])
### 3) Statut clinique
* Étude PRIME conduite sous **IDE de la FDA** (mai 2023), annoncé par l’entreprise et relayé par la presse. ([Neuralink][6])
* PRIME référencée comme **NCT06429735**. ([Neuralink][2])
* Premier implant humain (janvier 2024) et contrôle de curseur rapporté par Reuters. ([Neuralink][4])
* Désignation **Breakthrough Device** (FDA) pour une technologie de restauration de la communication, selon Reuters. ([Reuters][11])
---
**Note (all languages):** Neuralink devices are **investigational** in clinical trials; outcomes discussed publicly are early-stage and may not generalize. ([Neuralink][2])
[1]: https://neuralink.com/?utm_source=chatgpt.com "Neuralink — Pioneering Brain Computer Interfaces"
[2]: https://neuralink.com/trials/device-control/?utm_source=chatgpt.com "Device Control"
[3]: https://www.fiercebiotech.com/medtech/neuralink-implants-brain-computer-interface-first-human-trial-participant?utm_source=chatgpt.com "Neuralink implants brain-computer interface in first human"
[4]: https://neuralink.com/updates/prime-study-progress-update/?utm_source=chatgpt.com "PRIME Study Progress Update"
[5]: https://neuralink.com/updates/a-year-of-telepathy/?utm_source=chatgpt.com "A Year of Telepathy | Updates"
[6]: https://neuralink.com/updates/first-clinical-trial-open-for-recruitment/?utm_source=chatgpt.com "Neuralink's First-in-Human Clinical Trial is Open for ..."
[7]: https://clinicaltrials.gov/study/NCT06710626?utm_source=chatgpt.com "NCT06710626 | Control of Assistive Devices Via Brain- ..."
[8]: https://neuralink.com/updates/can-prime-study-launch/?utm_source=chatgpt.com "CAN-PRIME Study Launch | Updates"
[9]: https://www.reuters.com/business/healthcare-pharmaceuticals/neuralinks-first-human-patient-able-control-mouse-through-thinking-musk-says-2024-02-20/?utm_source=chatgpt.com "Neuralink's first human patient able to control mouse ..."
[10]: https://www.theguardian.com/science/2025/feb/08/elon-musk-chip-paralysed-man-noland-arbaugh-chip-brain-neuralink?utm_source=chatgpt.com "Elon Musk put a chip in this paralysed man's brain. Now he can move things with his mind. Should we be amazed - or terrified?"
[11]: https://www.reuters.com/business/healthcare-pharmaceuticals/neuralinks-speech-restoration-device-gets-fdas-breakthrough-tag-2025-05-01/?utm_source=chatgpt.com "Neuralink's speech restoration device gets FDA's 'breakthrough' tag"
[12]: https://www.statnews.com/2023/05/26/neuralink-fda-brain-computer-interface/?utm_source=chatgpt.com "Musk's Neuralink can now study its brain implant in humans"