Frequently Asked Questions

Brain Ultimate uses proprietary deionized-water liquid cooling rather than transformer oil or wax composites. That choice drives the rest of the system:

• Handling: No oil, no clay, no compounds
• Efficiency: Coils never need changing to cool
• Performance: Consistent delivery across a full treatment day
• Cost: No per-pulse or per-use fees

Works alongside Brain Ultimate Neuronavigation, Brain Ultimate Cloud and EB Neuro neurophysiology systems within the Brain Ultimate ecosystem.

TMS is an FDA-cleared, non-invasive treatment that uses focused magnetic pulses to stimulate targeted brain regions. Repeated sessions are associated with lasting improvement in depression.

Brain Ultimate holds three separate FDA clearances — K230735 (MDD), K243459 (OCD) and K243460 (iTBS) — and is backed by 200+ peer-reviewed studies involving over 5,000 participants.

• TMS M-Series device: Contact for pricing
• Coils: Liquid Double Cone $7,000; Figure-8 liquid-cooled $6,000; Figure-8 air-cooled $5,500
• Installation: On-site $3,000 (1–2 days), remote $1,200 (4–6 hours)
• Neuronavigation: Contact for pricing
• Brain Ultimate Cloud: Hosted from $150/mo base plus $75/mo per additional device, or $2,000 one time for on-site

Accessories are listed in our online store. Financing options are available through independent partners. Contact 1-888-570-2595.

• Frequency: 0.1–100 Hz
• Intensity: 0–200% MT software range, up to 100% system output
• Cooling: Proprietary deionized water, continuous operation
• Protocols: Four FDA-cleared
• Pulse type: Biphasic
• Coil lifespan: 50,000,000 pulses
• Software: QuickStim 3.3.9 with Cloud connectivity
• Thermal safety: Intelligent temperature monitoring with automated safety and protection systems
• Power: 230VAC/50Hz native; US installations use an included step-down transformer, 3500W draw, 5 kVA minimum dedicated circuit

Integrates with Brain Ultimate Neuronavigation, EB Neuro EEG and MEP monitoring within the Brain Ultimate ecosystem.

A HIPAA-compliant platform for TMS practice management, available in two delivery architectures:

• Hosted: Single-tenant on AWS. From $150/mo base plus $75/mo per additional device, up to five devices. $900 for six months or $1,650 annually. Backups run automatically each day.
• On-site: $2,000 one time, perpetual, no recurring fee. Covers server, router, setup and data migration; travel and installation labour are quoted separately. Single location. Backup is a scheduled external-drive routine the practice maintains.

Both support up to 10 additional computers per environment. Access is through approved devices running QuickStim. More on Brain Ultimate Cloud.

• Figure-8 liquid-cooled (flat): $6,000 — standard MDD treatment
• Figure-8 liquid-cooled (angulated): $6,000 — alternative positioning
• Liquid Double Cone: $7,000 — OCD treatment
• Figure-8 air-cooled: $5,500

All liquid-cooled coils use proprietary deionized water for continuous operation, weigh 1.3 kg, and are rated for 50,000,000 pulses.

• Minimum room: 10' × 12' (120 sq ft)
• Power: 230VAC/50Hz native; US installations require the included step-down transformer, 3500W draw, 5 kVA minimum dedicated circuit
• Operating temperature: 10–35°C
• Storage temperature: -20–60°C
• Included: Ergonomic chair, positioning arm, computer with software

• Daily: Visual inspection, startup verification
• Monthly: Cooling flow check, connection inspection
• Quarterly: System diagnostics, software updates
• Annual: Capacitor testing, full calibration

Coolant service intervals and refill thresholds are covered in your service plan and the instructions for use. Dedicated technical support is included.

An FDA-cleared 3D neuronavigation system built for Brain Ultimate TMS. An infrared optical camera tracks the treatment coil against a 3D model of the patient's head in real time, so every session lands on the same target, at the same angle.

• Imaging: Import the patient's own DICOM or NIfTI data, or work from a standard head model
• Targeting: Personalized MNI coordinates
• Guidance: Live angle and distance readouts through the session
• Software: Navigated sessions run in QuickVision — a single application handling navigation, targeting, stimulator control, protocol parameters, coil temperature and motor threshold

More on Brain Ultimate Neuronavigation.

No. Neuronavigation is cleared for spatial positioning and orientation of the treatment coil under the supervision of a tracking system.

No. All four FDA-cleared treatment protocols are delivered without it, using the 10-20 positioning caps and the coil arm.

Neuronavigation is for practices that want image-based targeting from the patient's own scan and documented session-to-session repeatability.

Yes. Neuronavigation is available for new systems and for systems already installed in your practice. Talk to us about your current configuration and we will confirm what is required.

Contact for pricing. Neuronavigation is configured with the system rather than sold as a fixed catalogue item, so pricing is quoted against your configuration. Request pricing or call 1-888-570-2595.

Brain Ultimate holds three FDA clearances:

• K230735 — Major Depressive Disorder
• K243459 — OCD
• K243460 — iTBS

Four cleared treatment protocols are available: Standard MDD at 19 minutes, Extended MDD at 37 minutes, iTBS at 3 minutes 12 seconds, and OCD at 18 minutes.

1. Preparation: The patient is seated in an ergonomic treatment chair
2. Positioning: The coil is positioned using a positioning cap
3. First session: A clinician establishes the appropriate stimulation level
4. Treatment: Runs for the protocol duration
5. Completion: The patient resumes normal activities immediately

Patients remain awake and alert throughout. They feel a tapping sensation and hear a clicking sound; earplugs are provided.

• Frequency: 5 sessions per week
• Duration: 4–6 weeks
• Total: Typically 20–30 sessions, with an optional maintenance taper

Session lengths: Standard MDD 19 minutes, Extended MDD 37 minutes, iTBS 3 minutes 12 seconds, OCD 18 minutes.

Intermittent Theta Burst Stimulation, FDA-cleared under K243460.

At 3 minutes 12 seconds it is the shortest of the four cleared protocols, which makes a materially higher daily patient throughput possible.

TMS is an established option for patients who have not responded to medication. The published literature reports meaningful response and remission rates, along with durable benefit where maintenance treatment is used.

Outcomes vary by patient, and the right expectation for any individual is a conversation with their treating clinician. Our research library collects the underlying studies.

• Medications: Patients can generally continue antidepressants
• Psychotherapy: A common complement
• EEG: EB Neuro systems integrate within the Brain Ultimate ecosystem for objective recording alongside a course of treatment

Your clinician determines the appropriate combination.

• FDA clearance: K243459
• Protocol: 18 minutes
• Course: Typically daily over about six weeks
• Coil: Liquid Double Cone ($7,000)

OCD treatment is most often considered for patients who have not responded to exposure and response prevention or to medication. Outcomes vary; your clinician is the right source for an individual expectation.

EB Neuro S.p.A. is Brain Ultimate's sister company — both sit under Hanix United — and Brain Ultimate is its exclusive North American distributor.

• Heritage: Founded early 1970s in Florence and Verona — 55+ years of Italian neurophysiology engineering
• Reach: Trusted in over 50 countries
• Regulatory: FDA 510(k) cleared under K242305

EEG: BE Plus PRO (22–128ch), BE Plus LTM (wireless, 272ch), BE Micro (72hr ambulatory), BE Micro aEEG (NICU), Neurotravel Light (51 inputs, USB powered), ICU EEG-SEP.

EMG/EP: NeMus 1, NeMus 2, NExT Station.

Software: Galileo NT.

All FDA cleared. Browse the EB Neuro range or contact 1-888-570-2595.

Yes — EB Neuro hardware and software are FDA 510(k) cleared under K242305 for clinical diagnostics, research, and long-term monitoring.

• Before treatment: Objective EEG recording to document a baseline
• During treatment: EEG monitoring where clinically indicated
• After treatment: Objective outcome recording
• MEP module: Available as an add-on
• Data: Galileo NT integration

EEG hardware pairs with the Brain Ultimate TMS system within our own ecosystem.

EB Neuro's unified neurophysiology software, FDA cleared. Modules cover EEG, EMG/EP, sleep, and ICU workflows, with HL7 and DICOM integration.

Dedicated technical support, operator training, professional installation, and service and calibration packages. Contact 1-888-570-2595 or service@brainultimate.com.

EEG records the brain's electrical activity. EB Neuro's systems are EEG acquisition and review platforms, used by clinicians for objective recording — for example to document a baseline before a course of TMS and to record again afterward.

More on EB Neuro EEG systems.

• Neurotravel Light: 51 total inputs — 32 monopolar, 8 bipolar, 8 additional, plus 3 optional channels (SpO2, HR, PLET). USB powered and compact, with compatibility across electrode types, specified for a modern 32-channel Video EEG laboratory.
• BE Plus PRO: 22–128ch, research-grade
• BE Micro: 19–21ch, 72-hour ambulatory recording

All use standard cloth positioning caps.

No. Brain Ultimate's four FDA-cleared protocols define how treatment is delivered.

EEG acquisition does not select a protocol, set a target, or optimize a course of treatment, and no such capability is claimed for these systems.

No — TMS is delivered effectively without it. Practices choose EEG where objective recording, outcome documentation, or research participation is valuable to them.

Quote-based, since configuration varies by channel count and workflow. All systems are FDA cleared under K242305. Contact 1-888-570-2595.

• On-site installation: 1–2 days, training delivered hands-on
• Remote installation: 4–6 hours, training delivered virtually
• Trainers: Certified by the Clinical TMS Society
• Covers: Device operation, safety, protocol delivery, QuickStim, troubleshooting, patient positioning
• Credential: Attendees receive a certificate of completion

Installation itself is priced separately — on-site $3,000, remote $1,200. Dedicated support continues afterward. More on training.

Practice-launch support is delivered by our partners rather than sold by Brain Ultimate. We introduce you; they deliver the service and quote their own pricing.

• Billing and practice setup: Metro NeuroHealth — practice forms, billing setup, operational training, with payer credentialing and rate negotiation available at higher tiers
• Clinical marketing: MHSS — lead capture, community outreach, and brand development for TMS clinics

1. Schedule a demo
2. Receive a customized quote
3. Choose a setup package (optional)
4. Place the order
5. Installation and training — 1–2 days on site or 4–6 hours remote
6. Launch and start treating patients

Typical timeline: 4–6 weeks from order. Contact us or call 1-888-570-2595.

The economics turn on three things: session reimbursement in your payer mix, how many patients you can treat in a day, and the length of a typical course.

Continuous cooling and the 3-minute iTBS protocol both work in favour of daily throughput, and there are no per-pulse fees to erode margin. The CPT codes used for TMS delivery are set out separately.

• Consumables: Positioning caps and earplugs, listed in our online store
• Maintenance: Scheduled service per your service plan
• Optional: Brain Ultimate Cloud — hosted from $150/mo base plus $75/mo per additional device, or $2,000 one time for on-site
• No per-pulse fees: Nothing charged per treatment delivered

Brain Ultimate introduces practices to independent equipment financing partners, who set their own terms and make their own credit decisions. Lease options and trade-in discussions are available. No per-pulse fees.

See financing partner options or call 1-888-570-2595.

• High-impact: 38 studies with an impact factor of 4.0 or higher
• Highest impact factor: 10.7 (MedComm)
• Breadth: 30+ research categories, 25 of them filterable
• Theses: 53

Browse the full research library.

Dozens of published studies use the M-100 platform specifically, with further work on related devices. Journals span the field, with impact factors reaching 10.7.

Yes — 150+ institutional partnerships, a regular presence at APA, CTMS, SfN and OHBM, and support for studies across depression, stroke, pain and other areas.

See our events calendar for where we will be next.

Our research library collects them, and they are also indexed on PubMed and Google Scholar.

TMS is generally well tolerated. The most commonly reported effects are mild and short-lived — scalp discomfort at the treatment site and mild headache.

Because TMS is not a systemic treatment, it does not carry the weight gain, sexual side effects, or sedation associated with some medications. Serious adverse events are rare.

Your clinician will review the full risk profile with you.

Every patient is screened before treatment. Implanted metallic or electronic devices in or near the head are the principal contraindication, and some are absolute. Common dental work is generally not a barrier.

FDA clearances: K230735 (MDD), K243459 (OCD), K243460 (iTBS).

Insurance: Medicare and many commercial plans cover TMS for treatment-resistant depression. Criteria commonly include a diagnosis of MDD, documented failure of prior antidepressant trials, and medical-necessity documentation.

Coverage and requirements vary by plan and region — verify with the specific payer. See our CPT codes reference for the codes used in TMS delivery.

• Thermal protection: Intelligent temperature monitoring with automated safety and protection systems
• Emergency stop: Immediate cessation
• Cooling: Proprietary deionized water — no oil, no clay, no compounds
• Software: Protocol safety limits enforced in QuickStim
• Coil tracking: Lifespan monitoring across the 50,000,000-pulse rating
• Positioning: Secure system prevents movement

Certified by five authorities: FDA, CE, NMPA, TGA, KFDA.

• United States: FDA — K230735, K243459, K243460
• Europe: CE Mark under MDR
• Australia: TGA
• South Korea: KFDA
• China: NMPA

Clearances are jurisdiction-specific and do not transfer between regions.