Frequently Asked Questions

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

• Handling: Removes the risks associated with transformer oil
• Efficiency: Runs continuously without cooling breaks
• Performance: Consistent delivery across a full treatment day
• Cost: No per-pulse or per-use fees

Works alongside 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)
• Brain Ultimate Cloud: Hosted from $150/mo base plus $75/mo per additional device, or $2,000 one time for on-site

Flexible financing available. Contact 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: 20,000,000 pulses
• Software: QuickStim 3.3.9 with Cloud connectivity
• Thermal safety: Dual-tier — warning tier plus automatic shutdown
• Power: 230VAC/50Hz native; US installations use an included step-down transformer, 3500W draw, 5 kVA minimum dedicated circuit

Integrates with 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 — enhanced 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 20,000,000 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.

Brain Ultimate holds three FDA clearances:

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

Four cleared protocols are available: Standard MDD at 19 minutes, Enhanced 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, Enhanced 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.

• 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
• Role: Brain Ultimate is the authorized North American distributor

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

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

Software: Galileo NT.

All FDA cleared. Browse the EB Neuro range or contact 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. Built on Microsoft SQL with HL7 and DICOM integration, and compatible with BESA, Persyst, and LORETA.

Dedicated technical support, operator training, professional installation, and service and calibration packages. Contact 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: 51ch, USB powered, portable — a compact setup
• 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 888-570-2595.

Training is included with every installation at no additional cost:

• On-site ($3,000): 1–2 days hands-on
• Remote ($1,200): 4–6 hours virtual
• Trainers: Certified by the Clinical TMS Society
• Covers: Device operation, safety, protocol delivery, QuickStim, troubleshooting, patient positioning
• Credential: Attendees receive a certificate of completion

Dedicated support continues afterward. More on training.

Practice-launch support is offered through our partner Metro NeuroHealth rather than sold by Brain Ultimate.

Packages start from $3,799 and cover practice forms, billing setup, and training, with payer credentialing and rate negotiation available at higher tiers. Metro NeuroHealth quotes their own current pricing.

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 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.

• Consumables: Positioning caps and earplugs
• 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

Yes — multiple financing partners, professional net terms, lease options, and trade-in discussions. No per-pulse fees. Contact 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.

• Thermal protection: Dual-tier — warning tier plus automatic shutdown
• Emergency stop: Immediate cessation
• Cooling: Proprietary deionized water, removing the handling risks associated with transformer oil
• Software: Protocol safety limits enforced in QuickStim
• Coil tracking: Lifespan monitoring across the 20,000,000-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.