ClinicalWhat has reached humans?

Clinical Pulse

Follow the BCI systems already being tested in people: where the studies are running, what stage each has reached and what has been reported. Stage, status and enrolment are shown as the public registry records them, and results are labelled by how they were published.

Almost every system on this page is experimental and available only through a clinical study. If you are considering taking part, the registry record and the study team are the right sources, not this page.

27
Human studies tracked: From the ClinicalTrials.gov registry; 10
Countries with study sites: Among the sites recorded here; 329
Participants planned or enrolled: Sum of registered enrolment; mostly estimates; 9
Studies with peer-reviewed results: Linked to a published paper

United States20
United Kingdom3
France2
China2
Canada1
United Arab Emirates1
Australia1
Switzerland1
Netherlands1
Germany1

First-in-human
Feasibility
Clinical study or Pivotal
Approved / cleared
Size: studies at site

2026

Fig. 01 — Where human studies are running27 studies started by 2026. Colour shows the most advanced stage at each site. Study sites recorded, by country. Registry data checked 3 Oct 2026.

Clinical stage — select to filter

27 studies

Stage	Registry status	Participants	Indication	Results
Pivotal	Active, not recruiting	38est.	Geographic atrophy due to AMD
Feasibility	Active, not recruiting	6act.	Severe paralysis, ALS
Feasibility	Recruiting	3est.	ALS, Severe speech and motor impairment
Feasibility	Active, not recruiting	3est.	Spinal cord injury
Feasibility	Recruiting	3est.	Paralysis, Anarthria
Feasibility	Recruiting	5est.	Tetraplegia
Feasibility	Recruiting	30est.	Tetraplegia, Spinal cord injury
Feasibility	Recruiting	27est.	Tetraplegia, Spinal cord injury
Feasibility	Recruiting	2est.	Severe speech and motor impairment
Feasibility	Recruiting	6est.	Severe speech impairment	None reported
First-in-human	Recruiting	4est.	Stroke
Pivotal	Completed	32act.	Tetraplegia, Spinal cord injury
Feasibility	Recruiting	15est.	Tetraplegia, Cervical spinal cord injury
Feasibility	Recruiting	5est.	Blindness	None reported
First-in-human	Completed	5act.	Severe bilateral upper-limb paralysis, ALS
Feasibility	Completed	6act.	Locked-in syndrome, ALS
Feasibility	Recruiting	4est.	Loss of speech	None reported
Feasibility	Recruiting	5est.	Paralysis	None reported
Feasibility	Recruiting	20est.	Treatment-resistant depression	None reported
First-in-human	Recruiting	1est.	Spinal cord injury	None reported
Clinical study	Recruiting	32est.	Tetraplegia, Spinal cord injury	None reported
Clinical study	Recruiting	34est.	Spinal cord injury	None reported
Feasibility	Recruiting	10est.	Severe paralysis	None reported
Feasibility	Recruiting	7est.	Tetraplegia, ALS	None reported
Feasibility	Recruiting	10est.	Tetraplegia, ALS	None reported
Feasibility	Recruiting	6est.	Tetraplegia, ALS	None reported
First-in-human	Completed	10act.	Brain tumour surgery (intraoperative mapping)	None reported

Regulatory milestones

Read the scope, not only the headline

A designation is not a clearance. A clearance for thirty days is not an approval for a permanent implant. Each entry below states exactly what was granted.

18 Sep 2026
US FDA · Breakthrough Device designation
CorTec — FDA Breakthrough Device designation for communication in non-progressive quadriplegia.
ScopeA designation speeds interaction with the regulator. It is not a clearance or approval.
22 Jul 2026
EU (notified body) · CE mark
Science Corporation — CE marking under the EU Medical Device Regulation for adults with geographic atrophy due to AMD.
ScopeMarketing authorisation in Europe for a defined indication. Not authorised in the United States.
28 Apr 2026
US FDA · Investigational device exemption
Motif Neurotech — FDA authorisation to begin the first clinical trial of the DOT stimulator in treatment-resistant depression.
ScopePermits a clinical study of an investigational device. Not a marketing authorisation.
8 Apr 2026
US FDA · Breakthrough Device designation
CorTec — FDA Breakthrough Device designation for stroke motor rehabilitation.
ScopeA designation speeds interaction with the regulator. It is not a clearance or approval.
13 Mar 2026
China NMPA · Medical device registration
Neuracle — The NMPA approves the registration of NEO, an implantable BCI system for hand motor function compensation: the first marketing authorisation for an implanted BCI.
ScopeAdults aged 18 to 60 with tetraplegia from C2–C6 cervical spinal cord injury, for assisted grasp with a pneumatic glove. A marketing authorisation in China only.
Nov 2025
US FDA · Investigational device exemption
Paradromics — FDA authorisation to begin the Connect-One early feasibility study.
ScopePermits a clinical study of an investigational device. Not a marketing authorisation.
Apr 2025
US FDA · 510(k) clearance
Precision Neuroscience — FDA clearance for use of the Layer 7 Cortical Interface for up to 30 days.
ScopeTemporary use of up to 30 days. Long-term implantation as a BCI is not covered.
24 Feb 2025
US FDA · Approval of adaptive deep brain stimulation
Medtronic — FDA approval of BrainSense Adaptive DBS and the BrainSense Electrode Identifier for Parkinson's disease.
ScopeStimulation that adjusts to local field potentials recorded by the same implant, for Parkinson's disease on Percept neurostimulators. A therapy that adapts to one signal; not a BCI authorisation.
19 Dec 2024
US FDA · De Novo marketing authorisation
ONWARD Medical — FDA De Novo marketing authorisation for ONWARD's external spinal cord stimulator. It is the company's authorised product and is not a brain-computer interface.
ScopeStimulation of the spinal cord through the skin, to improve hand strength and sensation in adults aged 18 to 75 with chronic incomplete cervical spinal cord injury. Nothing is read from the brain; the brain–spine interface remains investigational.
Aug 2024
China NMPA · Special review procedure for innovative medical devices
Neuracle — NEO is admitted to the NMPA's special review procedure for innovative medical devices.
ScopeA faster review route with closer contact with the regulator. It is not an authorisation.
Feb 2024
US FDA · Breakthrough Device designation
ONWARD Medical — FDA Breakthrough Device designation for the investigational ARC-BCI System, according to the company.
ScopeA designation speeds interaction with the regulator. It is not a clearance or approval.
30 Oct 2023
US FDA · Breakthrough Device designation
neuroloop — FDA Breakthrough Device designation for the baroloop vagus nerve stimulation system, according to the company.
ScopeA designation speeds interaction with the regulator. It is not a clearance or approval, and the indication is hypertension, not a BCI use.
4 May 2023
US FDA · Breakthrough Device designation
Cognixion — FDA Breakthrough Device designation for a non-invasive EEG and augmented-reality headset for communication, according to the company.
ScopeA designation speeds interaction with the regulator. It is not a clearance or approval.
Apr 2021
US FDA · De Novo marketing authorisation
Kandu — FDA De Novo marketing authorisation for the IpsiHand Upper Extremity Rehabilitation System, described by Washington University as the first FDA-authorised BCI for rehabilitation.
ScopeA non-invasive EEG system for upper-extremity rehabilitation in chronic stroke, by prescription. Granted to Neurolutions, now part of Kandu.
11 Feb 2021
US FDA · Breakthrough Device designation
BrainQ — FDA Breakthrough Device designation for an electromagnetic field therapy after stroke, according to the company.
ScopeA designation speeds interaction with the regulator. It is not a clearance or approval, and the device is a stimulation therapy, not a BCI.
24 Jan 2020
US FDA · 510(k) clearance
g.tec medical engineering — FDA 510(k) clearance for g.tec's system for mapping the cortex from high-gamma activity in intracranial recordings.
ScopeStatistical evaluation of high-gamma activity in intracranial EEG recorded with the company's amplifier, to be read together with the original waveform. A mapping aid for the surgical team. It is not an implant and not an interface for the patient to use.
2019
EU (notified body) · CE mark
g.tec medical engineering — g.tec reports medical approval of recoveriX, its BCI system for stroke rehabilitation, and describes it as a CE certified medical product.
ScopeMarketing in Europe as a medical product. Stated by the company; CE certificates are not published centrally and we have not seen this one.

Read the scope, not only the headline

CorTec — FDA Breakthrough Device designation for communication in non-progressive quadriplegia.

Science Corporation — CE marking under the EU Medical Device Regulation for adults with geographic atrophy due to AMD.

Motif Neurotech — FDA authorisation to begin the first clinical trial of the DOT stimulator in treatment-resistant depression.

CorTec — FDA Breakthrough Device designation for stroke motor rehabilitation.

Neuracle — The NMPA approves the registration of NEO, an implantable BCI system for hand motor function compensation: the first marketing authorisation for an implanted BCI.

Paradromics — FDA authorisation to begin the Connect-One early feasibility study.

Precision Neuroscience — FDA clearance for use of the Layer 7 Cortical Interface for up to 30 days.

Medtronic — FDA approval of BrainSense Adaptive DBS and the BrainSense Electrode Identifier for Parkinson's disease.

ONWARD Medical — FDA De Novo marketing authorisation for ONWARD's external spinal cord stimulator. It is the company's authorised product and is not a brain-computer interface.

Neuracle — NEO is admitted to the NMPA's special review procedure for innovative medical devices.

ONWARD Medical — FDA Breakthrough Device designation for the investigational ARC-BCI System, according to the company.

neuroloop — FDA Breakthrough Device designation for the baroloop vagus nerve stimulation system, according to the company.

Cognixion — FDA Breakthrough Device designation for a non-invasive EEG and augmented-reality headset for communication, according to the company.

Kandu — FDA De Novo marketing authorisation for the IpsiHand Upper Extremity Rehabilitation System, described by Washington University as the first FDA-authorised BCI for rehabilitation.

BrainQ — FDA Breakthrough Device designation for an electromagnetic field therapy after stroke, according to the company.

g.tec medical engineering — FDA 510(k) clearance for g.tec's system for mapping the cortex from high-gamma activity in intracranial recordings.

g.tec medical engineering — g.tec reports medical approval of recoveriX, its BCI system for stroke rehabilitation, and describes it as a CE certified medical product.