Frequently Asked Questions

Brain Ultimate is the ONLY TMS system using pure deionized water cooling instead of transformer oil. This revolutionary difference provides several key advantages:

• Safety: No risk of oil leaks, electric shocks, or contamination
• Efficiency: Operates continuously without cooling breaks
• Maintenance: Simple annual water replacement vs. complex oil changes
• Performance: Consistent treatment delivery all day long
• Cost: Most competitive pricing in the industry

Combined with our comprehensive Brain Ultimate Cloud connectivity and EB Neuro neurophysiology integration, we offer the most advanced accessible TMS solution in the market.

Transcranial Magnetic Stimulation (TMS) is an FDA-cleared, non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain. Here's how it works:

• Magnetic Pulses: The device generates focused magnetic field pulses (up to 100 Hz)
• Brain Stimulation: These pulses pass painlessly through the skull to stimulate targeted brain regions
• Neural Activity: The stimulation modulates neural activity in mood-regulating areas
• Treatment Effect: Repeated sessions lead to lasting improvements in depression and other conditions

Brain Ultimate TMS has been FDA-cleared for treating Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD), with proven efficacy in 176 peer-reviewed clinical studies involving over 5,000 participants.

Brain Ultimate offers the most competitive pricing in the industry for FDA-cleared TMS technology:

• TMS M-Series Device: Contact us for current equipment pricing
• Brain Ultimate Cloud: $150/month, $900/6 months, or $1,650/year
• Installation Services: On-site $3,000 (1-2 days), Remote $1,200 (4-6 hours)
• Accessories: Positioning caps $150/10-pack, Ear plugs $27/10 pairs

We offer flexible financing options to make Brain Ultimate accessible to practices of all sizes. Contact our team at 888-570-2595 ext 801 for a personalized quote and ROI analysis.

The Brain Ultimate M-Series offers industry-leading specifications:

• Frequency Range: 0.1 - 100 Hz
• Intensity: 0 - 120% Motor Threshold
• Cooling System: Patented deionized water (24/7 operation)
• Protocols: 4 FDA-cleared (Standard MDD, Enhanced MDD, iTBS, OCD)
• Pulse Type: Biphasic
• Coil Lifespan: 20 million pulses
• Software: QuickStim v3.3.8+ with cloud connectivity
• Auto-Shutdown: 41°C temperature protection

Our system is compatible with major neuronavigation systems, EEG monitoring, and MEP modules. Includes comprehensive safety features like automatic temperature monitoring and emergency stop capabilities.

Brain Ultimate Cloud is our HIPAA-compliant cloud platform launching March 2025 that transforms how you manage your TMS practice:

• Multi-Device Sync: Connect up to 5 TMS machines to one system
• Remote Access: Access patient data and protocols from anywhere
• Custom Shards: Each practice gets its own secure, isolated AWS cloud environment
• Automatic Backups: Never worry about data loss
• Practice Analytics: Track performance and patient outcomes
• Protocol Management: Store and share treatment protocols across devices

Pricing: $150/month (monthly), $900/6 months, or $1,650/year (save 1 month). Setup typically takes 2-3 business days with full support from our team.

Brain Ultimate offers specialized coils for different treatment needs:

• Figure-8 Liquid-Cooled Coil (Flat): $5,500 - Standard MDD treatment
• Figure-8 Liquid-Cooled Coil (Angulated): $5,500 - Enhanced positioning
• Liquid Double Cone Coil: $7,000 - NEW for OCD treatment
• Figure-8 Air-Cooled Coil: $5,500 - Budget option

All liquid-cooled coils benefit from our patented deionized water system, enabling continuous operation without breaks. Each coil is rated for 20 million pulses.

Brain Ultimate TMS has modest requirements that fit most clinical settings:

• Minimum Room Size: 10' x 12' (120 sq ft)
• Electrical: Standard clinical outlet (no special wiring needed)
• Operating Temperature: 10-35°C
• Storage Temperature: -20-60°C
• Included Equipment: Ergonomic electrical treatment chair, positioning arm, computer with software

Our compact design and efficient cooling system mean you don't need special ventilation or complex infrastructure. The system operates quietly and fits comfortably in most clinical settings.

Brain Ultimate requires minimal maintenance compared to oil-cooled systems:

• Daily: Visual inspection, startup verification
• Monthly: Cooling flow check, connection inspection
• Quarterly: System diagnostics, software updates
• Annual: Coolant replacement (deionized water), capacitor testing, full calibration

Unlike oil-cooled systems requiring complex maintenance procedures, our deionized water system simply needs annual water replacement. 24/7 technical support available.

Brain Ultimate TMS is FDA-cleared (K230735) for the following conditions:

• Major Depressive Disorder (MDD): Primary indication with excellent outcomes in 176 peer-reviewed studies
• Obsessive-Compulsive Disorder (OCD): FDA-cleared with dedicated 18-minute protocol

Our system offers 4 FDA-cleared treatment protocols to address different patient needs:

• Standard MDD Protocol: 19 minutes, 10Hz, 3000 pulses
• Enhanced MDD Protocol: 37 minutes, 10Hz, 3000 pulses
• iTBS Protocol: 3 minutes 12 seconds, 50Hz bursts, 600 pulses (accelerated treatment)
• OCD Protocol: 18 minutes, 20Hz, 2000 pulses

A typical TMS session with Brain Ultimate follows this process:

1. Preparation (5 min): Patient removes magnetic-sensitive items and is seated in our ergonomic treatment chair
2. Positioning (5 min): The TMS coil is positioned precisely using our positioning cap system
3. Motor Threshold (15 min, first session only): We determine the optimal stimulation level
4. Treatment (3-37 min): Magnetic pulses are delivered according to the selected protocol
5. Completion: Patient can immediately resume normal activities

Patients remain awake and alert throughout. They may feel a tapping sensation and hear clicking sounds (earplugs provided for comfort). Our QuickStim software monitors the entire session with automatic safety protocols.

A standard TMS treatment course typically involves:

• Frequency: 5 sessions per week (Monday-Friday)
• Duration: 4-6 weeks for acute treatment
• Total Sessions: 20-30 sessions typically
• Maintenance: Optional taper schedule for sustained benefits

Session length varies by protocol:

• Standard MDD: 19 minutes
• Enhanced MDD: 37 minutes
• iTBS: 3 minutes 12 seconds (allows 10+ patients per day)
• OCD: 18 minutes

Intermittent Theta Burst Stimulation (iTBS) is our newest FDA-cleared protocol (K243460) that revolutionizes TMS treatment:

• Duration: Just 3 minutes 12 seconds
• Efficacy: Comparable to standard 37-minute protocols
• Mechanism: Delivers 600 pulses in triplet bursts at 50Hz
• Benefits: Dramatically increases patient throughput (10+ patients/day possible)
• Research: Validated in multiple studies within our 176-publication research base

This accelerated protocol allows you to treat more patients per day while maintaining treatment effectiveness, significantly improving practice efficiency and patient access to care.

TMS has demonstrated strong efficacy for Major Depressive Disorder:

• Response Rate: 50-60% of patients show significant improvement
• Remission Rate: 30-40% achieve complete remission of symptoms
• Treatment-Resistant: Effective even after medication failures
• Durability: Benefits typically last 12+ months with maintenance

Yes, TMS is often most effective when combined with other treatments:

• Medications: Can continue antidepressants during TMS
• Psychotherapy: Excellent complement to talk therapy
• QEEG Assessment: Use our EB Neuro QEEG tools for treatment monitoring
• Neuronavigation: Compatible with major neuronavigation systems for precision targeting

Our integrated approach with EB Neuro neurophysiology tools allows comprehensive treatment planning and outcome monitoring.

Brain Ultimate's OCD protocol (K243459 FDA clearance) shows promising results:

• Protocol: 18 minutes, 20Hz, targeting supplementary motor area
• Duration: Typically 6 weeks of daily treatments
• Response: 30-40% show significant symptom reduction
• Application: Best for patients who haven't responded adequately to ERP therapy and medications

Our specialized Liquid Double Cone Coil ($7,000) is designed specifically for optimal OCD treatment delivery.

EB Neuro S.p.A. is now part of the Brain Ultimate family, bringing together 70+ years of Italian neurophysiology excellence with cutting-edge neuromodulation technology:

• Heritage: 70+ years of Italian neurophysiology innovation
• Global Reach: Serving 50+ countries worldwide
• FDA Cleared: ALL EB Neuro products are FDA 510(k) cleared (K242305)
• Integration: Seamless compatibility with Brain Ultimate TMS systems

EB Neuro offers comprehensive neurophysiology solutions across multiple categories:

EEG Systems:

• BE Plus PRO: Professional EEG platform (22-128 channels, 32,768 Hz sampling)
• BE Plus LTM: Wireless long-term monitoring (up to 272 channels)
• BE Micro: Ambulatory EEG (72-hour recording, 19-21 channels)
• BE Micro aEEG: NICU monitoring for HIE diagnosis
• Neurotravel Light: Portable EEG/QEEG (51 channels, USB powered)
• ICU EEG-SEP: Combined critical care monitoring

EMG/EP Systems:

• NeMus 1: Entry-level EMG (2 channels)
• NeMus 2: Polyvalent EMG/EP (2-4 channels + EP)
• NExT Station: Advanced EMG/EP (4-8 channels)

Software:

• Galileo NT: Unified neurophysiology platform with HL7/DICOM integration

All products are FDA cleared and available for quote-based pricing. Contact us at 888-570-2595 ext 801.

Yes, ALL EB Neuro hardware and software products are FDA 510(k) cleared:

• Clearance Number: K242305
• Coverage: All EEG systems, EMG/EP devices, and Galileo NT software
• Applications: Clinical diagnostics, research, long-term monitoring
• Compliance: Full US regulatory approval for medical use

This comprehensive FDA clearance ensures that EB Neuro products meet rigorous safety and efficacy standards for clinical neurophysiology applications.

EB Neuro products offer powerful integration opportunities with TMS therapy:

• Pre-Treatment Assessment: Use QEEG to identify optimal TMS targets
• During Treatment: Monitor brain activity in real-time with EEG
• Outcome Tracking: Objective measurement of treatment response
• MEP Monitoring: Our TMS systems include MEP module compatibility ($2,950)
• Data Integration: Galileo NT software connects with TMS protocols

This integrated approach enables precision neuromodulation with objective neurophysiological feedback.

Galileo NT is EB Neuro's unified neurophysiology software platform (FDA cleared):

• Modules: EEG_NET, NExT (EMG/EP), GALAXY_Sleep, ICU monitoring
• Database: Microsoft SQL for robust data management
• Integration: HL7 and DICOM standards for EMR connectivity
• Compatibility: Works with BESA, Persyst, and major analysis tools
• Workflow: Streamlined acquisition, analysis, and reporting

Galileo NT provides a comprehensive platform for all neurophysiology needs in one integrated system.

Brain Ultimate provides comprehensive support for all EB Neuro products:

• Technical Support: 24/7 assistance for all hardware and software
• Training: Comprehensive operator training included
• Installation: Professional setup and integration
• Maintenance: Full service and calibration packages
• Contact: 888-570-2595 ext 801 or support@brainultimate.com

Our team has decades of combined experience in neurophysiology and provides expert support across all product lines.

Quantitative EEG (QEEG) is an FDA-cleared assessment tool that provides objective brain activity measurements:

• Function: Records and analyzes electrical brain activity
• Application: Assessment tool ONLY - not for optimization or treatment planning
• Compatibility: Works with ANY TMS brand, not just Brain Ultimate
• Use Cases: Baseline assessment, treatment monitoring, outcome tracking
• Technology: Uses standard cloth positioning caps (NOT LED caps)

Several EB Neuro systems include QEEG assessment capabilities:

• Neurotravel Light: Portable QEEG solution (FDA cleared K242305)
  • 51 channels, USB powered
  • Perfect for mobile assessment
  • Ideal for TMS practices
• BE Plus PRO: Professional EEG with QEEG analysis
  • 22-128 channels
  • Research-grade acquisition
  • Comprehensive analysis tools
• BE Micro: Portable with QEEG option
  • 19-21 channels
  • 72-hour recording capability

All systems use standard cloth positioning caps with anatomical landmarks - no LED caps or electronic positioning systems.

EEG and QEEG serve different but complementary purposes:

EEG (Electroencephalography):

• Records raw brain electrical activity
• Visual interpretation by trained clinicians
• Diagnostic tool for seizures, sleep disorders, brain injuries
• Qualitative assessment

QEEG (Quantitative EEG):

• Statistical analysis of EEG data
• Compares to normative databases
• Objective, quantitative measurements
• Assessment tool for functional changes
• Useful for tracking treatment response

Both are assessment tools - neither provides treatment recommendations or protocol optimization.

No, QEEG is optional but can provide valuable assessment data:

• Not Required: TMS can be performed effectively without QEEG
• Optional Benefit: Provides objective baseline measurements
• Outcome Tracking: Helps quantify treatment response
• Research: Valuable for clinical studies and publications
• Practice Differentiation: Can enhance comprehensive assessment offerings

Many successful TMS practices operate without QEEG. The decision should be based on your practice goals and patient population.

EB Neuro QEEG equipment requires quote-based pricing due to configuration options:

• Neurotravel Light: Contact for quote - portable, entry-level QEEG
• BE Plus PRO: Contact for quote - professional-grade system
• BE Micro: Contact for quote - ambulatory option
• Accessories: Headcaps (8 sizes), electrodes, stimulators

Contact our team at 888-570-2595 ext 801 for detailed pricing based on your specific needs. All EB Neuro products are FDA cleared (K242305).

Comprehensive training is INCLUDED with your installation - no additional cost:

• On-Site Installation ($3,000): Includes 1-2 days hands-on training
• Remote Installation ($1,200): Includes 4-6 hours virtual training
• Topics Covered:
  • Device operation and safety protocols
  • Treatment protocol execution
  • Motor threshold determination
  • QuickStim software navigation
  • Troubleshooting and maintenance
  • Patient positioning and comfort
• Ongoing Support: 24/7 technical assistance after training

Unlike other vendors who charge $3,000+ for training separately, Brain Ultimate includes everything you need to start treating patients confidently.

Through our partnership with Metro NeuroHealth, we offer comprehensive practice setup packages. Note: These are NOT sold by Brain Ultimate - contact Metro NeuroHealth directly:

Scale Up TMS Package ($3,799):

• Policies, procedures, and customized clinical forms
• Billing setup with all major payer networks
• 2 TMS operations training courses
• Practice workflow optimization

Accelerator TMS Package ($6,300):

• Everything in Scale Up Package
• Contracting & credentialing for 8 payer networks
• Rate negotiations included
• Priority implementation support

Additional services available include website development, SEO/marketing, and ongoing operational consulting.

Getting started with Brain Ultimate is straightforward:

1. Schedule a Demo: See our technology in action (virtual or in-person)
2. Receive Quote: Get customized pricing for your practice needs
3. Choose Setup Package: Select Metro NeuroHealth support level (optional)
4. Place Order: Secure your delivery slot
5. Installation & Training: Our team handles everything (1-2 days on-site or 4-6 hours remote)
6. Launch: Start treating patients with confidence and ongoing 24/7 support

Timeline: Most practices are operational within 4-6 weeks from order placement.

Contact: Call 888-570-2595 ext 801 or email sales@brainultimate.com to begin.

TMS can provide strong ROI with proper practice setup:

• Reimbursement: $300-500 per session (varies by payer and region)
• Patient Volume: 8-12 patients per day possible with our 24/7 cooling
• Treatment Course: 20-30 sessions per patient
• Annual Revenue: $500K-1M+ potential per device

Contact us for a personalized ROI analysis based on your practice parameters and local market conditions.

Brain Ultimate has lower ongoing costs than oil-cooled competitors:

• Consumables:
  • Positioning caps: $150 per 10-pack
  • Ear plugs: $27 per 10 pairs
• Maintenance:
  • Annual coolant replacement (deionized water - simple and affordable)
  • Periodic calibration (recommended annually)
• Optional Services:
  • Brain Ultimate Cloud: $150/month
  • Extended warranty packages available

Our deionized water system significantly reduces maintenance costs compared to oil-cooled systems requiring complex servicing.

Yes, Brain Ultimate offers flexible financing to make our technology accessible:

• Payment Plans: Multiple financing partners available
• Professional Net Terms: Available for qualified practices
• Lease Options: Various term lengths to match your needs
• Trade-In: Discuss trade-in options for existing equipment

Contact our sales team at 888-570-2595 ext 801 to discuss financing options that work for your practice's budget and cash flow.

Brain Ultimate TMS is backed by extensive peer-reviewed research:

• Total Publications: 176 peer-reviewed studies
• High-Impact Research: Highest impact factor of 10.7
• Quality Studies: 42 publications with impact factor above 5.0
• Participants: Over 5,000 individuals in clinical studies
• Institutions: 150+ research partners worldwide
• Conditions Studied: 25+ different applications

Research Distribution by Condition:

• Stroke: 53 studies
• Depression: 16 studies
• Pain Management: 13 studies
• Other Conditions: 58 studies

Brain Ultimate demonstrates strong research credentials:

• Device-Specific Studies: 78 studies specifically using M-100 Ultimate
• Other Devices: 98 studies using other related devices
• Peer-Review Quality: Published in journals with impact factors up to 10.7
• Geographic Diversity: Research conducted across 50+ countries

Our commitment to evidence-based practice ensures that Brain Ultimate TMS is supported by rigorous scientific validation, not just marketing claims.

Yes, Brain Ultimate actively supports ongoing research initiatives:

• Research Partnerships: Collaboration with 150+ institutions globally
• Conference Presence: Regular attendance at APA, CTMS, SfN, OHBM
• New Applications: Supporting studies in stroke, pain, and other conditions
• Technology Development: Continuous innovation based on research findings

If your practice is interested in research collaboration, contact us to discuss partnership opportunities.

Brain Ultimate research is published in major scientific journals:

• Website: Visit brainultimate.com/research for publication list
• PubMed: Search for "transcranial magnetic stimulation" + specific conditions
• Google Scholar: Comprehensive academic search
• Impact Factors: Look for studies in journals with IF >5.0 for highest quality

Our research page provides direct links to key publications demonstrating efficacy across multiple conditions and protocols.

TMS is generally well-tolerated with minimal side effects:

Common (mild):

• Scalp discomfort at treatment site (usually decreases over time)
• Mild headache (treatable with over-the-counter pain relievers)
• Facial muscle twitching during treatment
• Lightheadedness (rare)

Rare (less than 0.1%):

• Seizures (extremely rare with proper screening)
• Temporary hearing issues if earplugs not used properly

NOT experienced with TMS:

• No weight gain
• No sexual dysfunction
• No sedation or cognitive impairment
• No gastrointestinal issues
• No systemic side effects like medications

TMS is contraindicated for patients with non-removable metal in or near the head:

Absolute Contraindications:

• Aneurysm clips or coils
• Stents in neck or brain
• Deep brain stimulators
• Cochlear implants
• Metallic implants in ears or eyes
• Shrapnel or bullet fragments in head/neck
• Facial tattoos with metallic ink
• Any other metal devices or implants near the head

Generally Safe:

• Dental fillings
• Dental braces
• Titanium skull plates (discuss with physician)

Important: Always conduct thorough screening using standardized TMS safety checklist before treatment.

Yes, Brain Ultimate TMS has full FDA clearance with broad insurance coverage:

FDA Clearances:

• MDD: K230735 (September 2023)
• OCD: K243459 (2024)
• iTBS: K243460 (2024)

Insurance Coverage: Most major insurance companies now cover TMS for treatment-resistant depression:

• Medicare (national coverage)
• Blue Cross Blue Shield (most plans)
• Aetna
• Cigna
• United Healthcare
• Humana
• Many regional and employer-based plans

Typical coverage requirements include:

• Diagnosis of Major Depressive Disorder
• Failure of 2-4 adequate antidepressant trials
• Current moderate-to-severe depression symptoms
• Medical necessity documentation

Our partner Metro NeuroHealth provides billing support and prior authorization assistance.

Brain Ultimate TMS includes comprehensive safety systems:

• Temperature Monitoring: Real-time tracking with automatic shutdown at 41°C
• Emergency Stop: Immediate treatment cessation capability
• Cooling System: Deionized water eliminates oil leak and shock risks
• QuickStim Software: Built-in protocol safety limits
• Coil Lifespan Tracking: Automatic monitoring of 20M pulse lifecycle
• Patient Positioning: Secure positioning system prevents movement during treatment

Our safety systems meet or exceed all FDA requirements and international safety standards (CE, TGA, KFDA, NMPA/CFDA Class III).

Brain Ultimate TMS maintains comprehensive global regulatory approvals:

• USA: FDA cleared (K230735, K243459, K243460)
• Europe: CE Mark & MDR compliant
• Australia: TGA approved
• South Korea: KFDA cleared
• China: NMPA/CFDA Class III approved

This comprehensive regulatory clearance demonstrates our commitment to meeting the highest safety and efficacy standards worldwide. Active in 50+ countries globally.