Neuronavigation for TMS | Brain Ultimate
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FDA CLEARED

Brain Ultimate Neuronavigation

See exactly where you are treating.

Brain Ultimate Neuronavigation tracks the treatment coil against a 3D model of your patient's head in real time — so every session lands on the same target, at the same angle, with confidence you can document.

  • Real-Time Coil Tracking
  • Personalized MNI Targeting
  • Individual Imaging or Common Mode
  • Session-to-Session Repeatability
The Brain Ultimate Neuronavigation device beside its optical tracking camera, on a plain background.

At a glance

FDA Cleared
One Application for Navigation, TMS and MEP
Functional and Structural Imaging
75+ Clinics Nationwide
PRECISION TARGETING

From Coordinate to Cortex

Optical tracking that connects your treatment plan to the patient in front of you.

Neuronavigation uses an infrared optical camera to follow two tracking tools — one on the treatment coil, one on the patient's head — and registers both to a 3D head model. The result is a live picture of exactly where the coil sits relative to the intended target, updated continuously throughout the session.

  • Registered to the PatientA short calibration at the start of each session maps the patient's real-world anatomy to the on-screen model using standard landmarks.
  • Tracked ContinuouslyHead and coil positions are followed in real time. If either moves, the display moves with it.
  • Documented AutomaticallyEvery session writes to the treatment record, with reports generated from your chosen template.
A clinician adjusts the overhead optical tracking camera on its articulated arm, with the neuronavigation software displayed on the monitor below.
THE FULL PICTURE

The Right Spot at the Wrong Angle Is Not the Same Target

Location alone does not define a treatment site — and neither does the scalp.

A patient's cortical parcellation displayed beneath a translucent scalp in the 3D view, with the tracked treatment coil positioned above it.

A target is six values, not three

Position tells you where on the scalp the coil sits. Orientation — pitch, roll, and yaw — tells you how it is tilted and which way the handle points. Induced field strength and direction depend on both, so the same scalp location at a different coil angle delivers a different treatment. Neuronavigation tracks all six continuously, which is what makes a target reproducible from one session to the next.

And the scalp is not the cortex

Scalp-landmark methods estimate a cortical location from external measurements. They are quick, they need no imaging, and they are the reason TMS scaled. But head shape, cortical folding, and the depth from scalp to target all vary between people, so the same measurement lands in a different place on a different head.

What navigation adds

Navigation replaces an estimate with a measurement. The target is chosen once, in the patient's own anatomy, and then found again at every session rather than re-estimated at every session.

Coil angle is set as part of the target and carried forward with it.
THE EVIDENCE

Does Targeting Actually Change Outcomes?

A randomized trial put the question directly, with targeting as the only variable.

Imaging routinely guides procedures across medicine. Psychiatry has been the exception — imaging is common in research and rare in practice, and TMS has been targeted with scalp landmarks since it was first cleared. Whether individualized, imaging-based targeting actually produces better outcomes was widely assumed and rarely tested head to head.

In a randomized clinical trial published in JAMA Psychiatry in June 2026, investigators at the Center for Brain Circuit Therapeutics at Mass General Brigham and Harvard Medical School tested it directly. Forty adults with treatment-resistant depression received the same stimulation protocol. The only difference between the two groups was how the treatment target was chosen: individualized functional-connectivity imaging, or the scalp-based Beam F3 method.

Response rate 80% vs 60%

Connectivity-based versus scalp-based targeting at one month.

Number needed to scan 5

Five patients scanned for one additional responder. Seven for one additional remission.

Effect size 0.8

95% CI 0.26–1.54, favouring connectivity-based targeting (P = .02).

Target reproducibility 4.47 mm

Median within-patient distance between independently derived targets, against 12.97 mm between patients (P < .001).

The finding that is about navigation. The first three figures are about which target to choose. The fourth is about whether a target can be found again — and that is what a navigation system does. Individualized targets were tightly reproducible within a patient and clearly different between patients. A target worth choosing is only worth choosing if it can be hit again at the next session.

Brain Ultimate Neuronavigation was not the system used in this trial. Taylor JJ, Kare MR, Haj-Darwish D, et al. Connectivity- vs scalp-based targeting of accelerated transcranial magnetic stimulation for depression: a randomized clinical trial. JAMA Psychiatry. Published online June 24, 2026. doi:10.1001/jamapsychiatry.2026.1100

LIVE GUIDANCE

Guidance That Holds Through the Session

Offset tracking keeps treatment inside the zone you define.

The live guidance display during a session, with the Real time offset panel reading the coil's angle and distance from target beside adjustable accuracy and threshold parameters, as the tracked coil is brought toward the 3D head model.

Once a target is set, the system displays live offset — how far the coil is from the target in distance, and how far off in angle. A semi-transparent guide coil shows the ideal position. Bring distance inside the accuracy zone first, then angle; small movements have a large effect once you are close.

Accuracy zone

The inner tolerance. Both distance and angle must be inside it before stimulation starts, and it is enforced for the whole session.

Threshold zone

The outer warning band. During an active session the coil may drift into it and stimulation continues, but repositioning is needed.

If the coil leaves the threshold zone, stimulation pauses automatically and resumes when the coil is brought back over the target.
FIVE WAYS IN

Set Targets the Way You Work

Standard sites, published coordinates, the patient's own imaging, or the position you just found by hand.

The target creation panel open beside the 3D view, with the treatment coil positioned over the cortical parcellation.

Standard 10-20 sites

Select a common site from the 10-20 dropdown, such as F3 for the left DLPFC.

MNI coordinates

Enter published coordinates directly, or scroll the slice views and click to capture a point.

The patient's own imaging

Import the patient's functional and structural scans and derive personalized MNI coordinates in the same software.

Directly on the model

Click the target on the 3D head, then drag and rotate the virtual coil to fine-tune position and angle.

Save current coil position

With calibration complete, hold the real coil where you want it and record that position as the target.

Imaging import — two formats, two behaviours

  • DICOMCarries both functional and structural data and produces a pre-made 3D model of the patient's head, ready to target against.
  • NIfTIImports as slices, navigated in the slice views.
  • Either format yields personalized MNI coordinatesComputed in the navigation software. No separate analysis package and no export step.

Head models

  • Common modeFor patients without imaging. Standard atlases: adult male, adult female, adolescent, and child.
  • Individual imagingThe patient's own scans, with anterior commissure alignment so MNI targets map to that patient's anatomy.
A stimulation plan holds multiple targets and protocols, saves to the patient profile, and reloads on the patient's next visit.
ONE INTEGRATED SYSTEM

Navigation, Stimulation and Threshold in One Application

One application, one record, one workflow.

The neuronavigation software main window, showing tracker and calibration controls, coil settings, a 3D head model with the tracked coil above it, three orthogonal slice views, and the stimulation planning and control panels together on one screen.

Brain Ultimate Neuronavigation is built by Brain Ultimate rather than integrated from a third-party navigation product. QuickVision handles all of it — navigation and targeting, stimulator control, protocol parameters, coil temperature, and motor threshold determination — in a single application. There is no second application to open, no window to switch between mid-session, and no separate record to reconcile afterwards.

In practice that means the clinician who is positioning the coil is looking at the same screen that is running the protocol. Target, offset, stimulator status and thermal state are read together rather than assembled from two systems that do not know about each other.

  • Drives Brain Ultimate TMS protocols directly — rTMS, cTBS, iTBS, and paired-pulse
  • Motor threshold with or without the MEP Module, including paired-pulse thresholds
  • Live coil temperature and stimulator status alongside the target view
  • Treatment records and reports generated in the same session
Dosing. Output intensity is the patient's motor threshold multiplied by the protocol's intensity percentage. Motor threshold percentage and delivered output are not the same number.
IN PRACTICE

A Session, Start to Finish

A clinician uses a tracked calibration pointer to map reference coordinates on the patient's head, with the 3D head model shown on the navigation display.
  1. Select the patientNew profile, or load an existing one with its saved plan and calibration.
  2. Load or create the planHead model, targets, and bound protocols in one container.
  3. Confirm motor thresholdDetermine it for new patients; returning patients carry a stored value.
  4. CalibrateHead first, then coil. Both indicators turn green before you continue.
  5. PositionBring distance, then angle, inside the accuracy zone and lock the arm.
  6. TreatStart, monitor, and stop. The session logs itself and the report is generated from the record.
With an unchanged setup and a reloaded plan, a returning patient's session picks up at calibration.
BUILT-IN SAFEGUARDS

Monitoring That Does Not Depend on Watching

Automatic Pause on Drift

Stimulation pauses if the coil leaves the threshold zone and resumes once it is back on target.

Thermal Protection

Coil and stimulator temperatures are monitored continuously, with automatic protective response at defined limits.

Calibration Integrity

The selected coil type must match the coil in use. A mismatch invalidates calibration, and the system is explicit about it.

SYSTEM COMPONENTS

What Ships With the System

Close-up of the treatment coil and the optical tracking sensor positioned on the patient's head, with reference markers secured before tracking begins.
  • Infrared tracking cameraFollows the coil and patient tracking tools throughout the session.
  • Coil tracking toolMounts to the treatment coil with an adjustable bracket.
  • Patient tracking toolHeadband or glasses, positioned opposite the treatment site.
  • Calibration probeRegisters anatomical landmarks and coil reference points.
  • Navigation workstationDual-display host running the QuickVision software, with dark and light themes and English language support.
Verify all components are present and undamaged before each session. Contact Brain Ultimate for missing or damaged items.
SPECIFICATIONS

System Specifications

Brain Ultimate Neuronavigation specifications
ItemDetail
System type3D optical neuronavigation for transcranial magnetic stimulation
TrackingInfrared optical, coil and patient tracking tools
Coordinate spaceMNI, with anterior commissure alignment on individual models
Head modelsCommon mode standard atlases (adult male, adult female, adolescent, child) or individual patient imaging
Imaging formatsDICOM — functional and structural, produces a pre-made 3D head model. NIfTI — imports as slices.
Personalized targetingPersonalized MNI coordinates derived from the patient's own imaging, computed in the navigation software
SoftwareQuickVision — navigation, targeting, stimulation control and motor threshold in a single application
ProtocolsrTMS, cTBS, iTBS, and paired-pulse variants
Motor thresholdWith or without MEP Module; single and paired-pulse; 2- or 4-channel acquisition
Pairs withBrain Ultimate TMS (M-Series) and the MEP Module
ReportingTreatment records with template-based report generation and batch export
RegulatoryFDA 510(k) cleared — K261228
PricingContact for pricing
REGULATORY

Regulatory Statement

Brain Ultimate Neuronavigation is FDA-cleared under K261228 for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.

Stimulation is delivered by the Brain Ultimate TMS system, which holds three separate 510(k) clearances: K230735 for Major Depressive Disorder and K243459 for Obsessive-Compulsive Disorder, which are its cleared indications, and K243460 for intermittent theta burst stimulation, which is a cleared modality.

Navigation supports the delivery of cleared protocols. It does not extend the cleared indication set.

Product documentation supplements, and never replaces, the Instructions for Use. Consult the IFU for warnings, contraindications, and full regulatory information.

Bring Precision Targeting to Your Practice

Neuronavigation is available for new Brain Ultimate TMS systems and as an addition to systems already in service. Contact us for pricing and configuration.

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