Is Neuralink FDA approved?

No. Neuralink is not FDA approved for commercial use as of 2026. Neuralink received an Investigational Device Exemption (IDE) from the FDA in May 2023, allowing it to conduct the PRIME feasibility study in humans. The N1 implant has also received FDA Breakthrough Device Designation for the Blindsight visual prosthesis application (September 2024). Full FDA approval — premarket approval (PMA) — would require completing larger pivotal clinical trials demonstrating safety and efficacy. Neuralink is currently in the feasibility study phase, which typically precedes a pivotal trial by several years.

Which BCIs have FDA approval?

As of 2026, no brain-computer interface designed for motor control or communication has received full FDA premarket approval (PMA). The only FDA-approved implantable brain device that functions similarly is the NeuroPace RNS System, which is approved for refractory epilepsy and uses responsive neurostimulation (not BCI motor decoding). Deep brain stimulation (DBS) systems from Medtronic, Abbott, and Boston Scientific are FDA-approved for movement disorders but are not BCIs. Precision Neuroscience received FDA 510(k) clearance for its Layer 7 cortical interface for temporary implantation (up to 30 days) for epilepsy monitoring.

What is a Breakthrough Device Designation?

FDA Breakthrough Device Designation is a regulatory pathway created under the 21st Century Cures Act (2016) for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. Designation provides: (1) priority review and faster feedback from FDA, (2) pre-submission meetings, (3) flexible clinical trial designs, and (4) senior management involvement in review. It does not guarantee approval or change the safety/efficacy requirements. Neuralink (Blindsight), Synchron, and ONWARD Medical have all received Breakthrough Device Designation for their BCI or neural interface products.

BCI.INTEL

NLINKN1 Chip+PRIME.StudySYNCRStentrode+$75M.SeriesDPRECNLayer 7+FDA.BrkthruPARAMArgo+$20M.SeriesBBLKRKNeuroport+200.ImplantsEMTIVMN8+$45M.SeriesBKRNLFlux+Non-invasiveNRBLEHalo+Consumer.BCINEURONeuroPace+RNS.SystemCOGNICognixion+ALS.TrialFUND.YTD2026$2.8B.SectorTRIALSActive50+.ClinTrialsIMPLNTSHumans~100.Intracrtnl

Home/Clinical Trials/FDA Approval Tracker

REGULATORY TRACKER // FDA PIPELINE

BCI FDA Approval Tracker: Every Brain Implant in the Pipeline

No brain-computer interface for motor control has received full FDA approval (PMA) as of 2026. Every BCI implant from Neuralink, Synchron, and Precision Neuroscience is either in feasibility studies or preparing for pivotal trials. This tracker monitors every BCI device in the FDA pipeline: Investigational Device Exemptions (IDEs), Breakthrough Device Designations, 510(k) clearances, and the path to premarket approval.

DEVICES IN PIPELINE

Active FDA submissions

BREAKTHROUGH DESIGNATIONS

Neuralink, Synchron, ONWARD, +1

IDE STUDIES ACTIVE

Feasibility & pivotal

FDA-APPROVED BCIS

NeuroPace RNS (epilepsy)

FDA Pipeline: All BCI Devices

Device	Company	FDA Pathway	Status	Breakthrough	Phase	Patients
Neuralink N1	Neuralink	De Novo / PMA	IDE — Feasibility study (PRIME)	Yes (Blindsight)	Feasibility	21
Neuralink Blindsight	Neuralink	PMA	Breakthrough Device Designation	Yes	Pre-clinical	0
Synchron Stentrode	Synchron	PMA	Breakthrough Device Designation	Yes	Feasibility complete; pivotal prep	10
Precision Layer 7	Precision Neuroscience	510(k) / PMA	510(k) cleared (30-day)	No	Expanding indications	37+
Blackrock NeuroPort	Blackrock Neurotech	IDE	IDE (research use)	No	Long-term feasibility	40+
Paradromics Connexus	Paradromics	IDE (planned)	Pre-submission	No	Pre-clinical / IDE prep	0
ONWARD ARC-BCI	ONWARD Medical	PMA	Breakthrough Device Designation	Yes	Clinical trials	12+
NeuroPace RNS	NeuroPace	PMA	FDA Approved (2013)	N/A	Commercial	4,000+

Active FDA Clinical Trials

These are the active FDA-regulated clinical trials for brain-computer interface devices, sourced from ClinicalTrials.gov and company filings.

PRIME Study: Feasibility of the Precise Robotically Implanted Brain-Computer Interface

RECRUITING

Sponsor: Neuralink Corp | Device: N1 Implant (1,024-electrode, 128 flexible threads) | Phase: feasibility

Enrollment: 21/30 | NCT: NCT06429735

CONVOY: Control of Assistive Devices Via Brain-Computer Interface Using the N1 Implant

RECRUITING

Sponsor: Neuralink Corp | Device: N1 Implant with ARA Robotic Arm | Phase: feasibility

Enrollment: 3/3 | NCT: NCT06710626

GB-PRIME: Great Britain Feasibility Study of the N1 Brain-Computer Interface

RECRUITING

Sponsor: Neuralink Corp | Device: N1 Implant | Phase: feasibility

Enrollment: 7/10 | NCT: NCT06992596

SWITCH: Stentrode With Thought-Controlled Digital Switch — First-in-Human Study (Australia)

COMPLETED

Sponsor: Synchron | Device: Stentrode (endovascular BCI) | Phase: feasibility

Enrollment: 4/5 | NCT: NCT03834857

COMMAND: Early Feasibility Study of the Synchron Stentrode for Severe Motor Paralysis (US)

COMPLETED

Sponsor: Synchron | Device: Stentrode (endovascular BCI) | Phase: feasibility

Enrollment: 6/6 | NCT: NCT05035823

Synchron Stentrode Pivotal Trial for FDA Approval

NOT YET RECRUITING

Sponsor: Synchron | Device: Stentrode (next-generation) | Phase: pivotal

Enrollment: 0/60 | NCT: pending

Layer 7 Cortical Interface Acute Intraoperative Recording Study

ACTIVE

Sponsor: Precision Neuroscience | Device: Layer 7 Cortical Interface (1,024 microelectrodes) | Phase: feasibility

Enrollment: 50/100 | NCT: NCT05764083

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons with Tetraplegia

ACTIVE

Sponsor: BrainGate Consortium / Massachusetts General Hospital | Device: Utah Array (96-electrode, Blackrock Microsystems) | Phase: feasibility

Enrollment: 14/27 | NCT: NCT00912041

Understanding FDA Pathways for BCIs

Investigational Device Exemption (IDE)

Allows a device to be used in a clinical study to collect safety and efficacy data. Required before any human testing. Neuralink and Blackrock operate under IDEs.

Breakthrough Device Designation

Provides priority review and intensive FDA interaction for devices treating life-threatening conditions. Does not change approval requirements. Neuralink (Blindsight), Synchron, and ONWARD have this designation.

510(k) Clearance

Demonstrates substantial equivalence to an already-marketed device. Faster but limited to predicate devices. Precision Neuroscience used this for its Layer 7 (30-day implant for epilepsy monitoring).

Premarket Approval (PMA)

The most rigorous FDA pathway, requiring extensive clinical data. NeuroPace RNS is the only brain device with PMA for chronic implantation. All motor BCIs will likely need PMA.

De Novo Classification

For novel devices with no predicate. Creates a new regulatory classification. Some BCIs may pursue De Novo if they cannot identify a predicate device for 510(k).

BOTTOM LINE // VERDICT

No Motor BCI Has Full FDA Approval Yet

As of March 2026, every BCI implant for motor control or communication is in the clinical trial phase. Neuralink and Synchron are the furthest along, with active feasibility studies and Breakthrough Device Designations. The path from feasibility study to FDA approval (PMA) typically takes 5 to 10 years and requires a successful pivotal trial. The earliest realistic date for a commercially approved BCI for paralysis is 2028 to 2030.

NeuroPace RNS remains the only FDA-approved chronic brain implant, and it was designed for epilepsy, not BCI.

Frequently Asked Questions

Last updated: March 2026 · Source: bciintel.com

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