FDA-Cleared TMS Devices Compared: Ampa One, NeuroStar, BrainsWay, MagVenture & Magstim

This comparison evaluates the five FDA-cleared TMS devices against the same clinical and business criteria, so you can match the right device to your practice's indication mix, patient volume, and financial model. No single device dominates every category, and each carries distinct trade-offs that matter for different practice models. NeuroStar dominates market share but charges $60-$100 per session in manufacturer fees. BrainsWay covers the broadest indication set including smoking cessation. MagVenture pioneered iTBS protocols with liquid-cooled efficiency.

Clinicians evaluate devices across coil type (figure-of-8 versus H-coil), treatment protocols (standard rTMS versus 3-minute iTBS), neuronavigation capability, and business model transparency. Patients want to know which device treats their condition most effectively, while practices need to know which device fits their workflow and financial structure.

This comparison covers the five primary FDA-cleared devices with editorial independence. We maintain no financial relationships with any manufacturer and evaluate each device against the same clinical and business criteria that matter for real TMS practices.

What Is a TMS Device?

A TMS device delivers focused magnetic pulses to targeted brain regions through the skull without surgical invasion. The magnetic field temporarily alters neural activity in specific cortical areas, offering a non-pharmaceutical treatment for psychiatric conditions like depression and OCD.

Every TMS system contains three core components: a magnetic stimulator that generates the pulses, a coil that focuses the magnetic field, and a positioning system to target the correct brain region. The stimulator creates brief, powerful magnetic pulses up to 2 Tesla in strength, while the coil shapes and directs this energy to penetrate roughly 2-3 centimeters into brain tissue.

Two coil families dominate the market. Figure-of-8 coils create focal stimulation in a concentrated area roughly the size of a quarter. H-coils produce more diffuse stimulation across wider brain regions but with less precision. Manufacturers like BrainsWay market this as "Deep TMS," though both coil types penetrate similar depths, and the distinction reflects stimulation breadth rather than depth.

Three treatment protocols define modern TMS delivery. Standard rTMS delivers 10 Hz pulses over 37.5 minutes per session. iTBS (intermittent theta burst stimulation) compresses equivalent therapeutic doses into 3-minute sessions. Accelerated TMS protocols like ONE-D deliver multiple daily sessions over compressed timeframes instead of spreading treatment across 6-8 weeks.

FDA clearance operates indication by indication, and each psychiatric condition requires separate approval. No single device holds clearances for every indication, making the choice of device dependent on your patient population and treatment goals.

How We Evaluated These Devices

We assessed each TMS device across seven core criteria that directly impact clinical practice and patient outcomes. FDA clearance breadth determines which conditions you can treat, since not all devices share the same approved indications. Coil type and stimulation parameters affect treatment precision, with figure-of-8 coils providing focal stimulation while H-coils offer deeper, more diffuse coverage.

Treatment protocols and session duration create the biggest workflow differences. Standard rTMS takes 37.5 minutes per session, while iTBS reduces this to 3 minutes, an important efficiency factor for high-volume practices.

Neuronavigation capability ranges from none (NeuroStar, BrainsWay) to included camera systems (Ampa One) to MRI-compatible options (MagVenture). Business models vary widely: traditional purchase, leasing, or pay-per-use arrangements that charge $60-$100 per session to manufacturers. We also evaluated ease of use, technical support quality, and warranty terms that affect long-term operational costs.

1. Ampa One

Quick Overview

Ampa One enters the TMS market as a US-based startup with a clinician-designed approach that prioritizes workflow efficiency. We offer two coil options: the L coil (focal stimulation, equivalent to figure-of-8) and M coil (diffuse stimulation, comparable to H-coil technology). The L coil holds FDA clearance specifically through the iTBS protocol, positioning Ampa One around faster treatment delivery rather than traditional rTMS approaches.

The system includes integrated camera-based navigation without additional hardware costs. Ampa One is built around the ONE-D accelerated TMS protocol, making it the only device purpose-engineered for this compressed treatment timeline.

Best For

Practices that want to implement accelerated TMS as their primary treatment approach benefit most from Ampa One's design. Clinics that want simpler workflows and less session complexity will find our interface advantageous.

Pros

Ampa One delivers the only TMS system built specifically for ONE-D accelerated protocols from inception. The integrated camera-based navigation eliminates the typical add-on costs that other devices require for precise targeting. Having both focal (L) and diffuse (M) coils gives practices flexibility to address different stimulation needs without purchasing separate systems.

The compact, nearly portable design reduces space requirements compared to traditional cart-based systems. Clinicians report shorter training curves due to the simplified, purpose-built interface. iTBS clearance enables 3-minute sessions instead of the 19–37.5 minute protocols that older systems require.

Cons

The leasing-only business model prevents practices from purchasing the device outright, which some clinicians prefer for long-term cost control and asset ownership. As a newer market entrant, Ampa One lacks the extensive reliability data and established support network that older manufacturers provide.

Pricing

Ampa One operates exclusively through a leasing model with rates available by contacting the manufacturer directly. No per-session fees apply to the practice once the lease agreement is established.

2. NeuroStar (by Neuronetics)

Quick Overview

NeuroStar holds the distinction of being the first FDA-cleared TMS device in the United States, receiving approval in 2008. The system uses a traditional figure-of-8 coil with three protocol options: Standard (37.5 minutes), DASH (19 minutes), and the newer TouchStar iTBS (3 minutes). NeuroStar maintains the largest US market share and has accumulated extensive clinical outcomes data through its NeuroStar Advanced Therapy registry.

The device relies on Contact Sensing technology for coil placement verification rather than neuronavigation systems. This approach prioritizes consistency with anatomical landmarks over individualized MRI-based targeting.

Best For

Practices that prioritize established clinical evidence and broad manufacturer support networks. NeuroStar fits clinics wanting the confidence of the largest installed base and most extensive outcomes tracking in American TMS.

Pros

NeuroStar offers the broadest FDA clearance portfolio, covering major depressive disorder, OCD, anxious depression, and adolescent depression for patients 15 and older. The device benefits from extensive clinical validation through thousands of treatments and extensive outcomes registry data. Neuronetics provides thorough training programs and maintains the most established support infrastructure in the US TMS market.

The company's early market entry means most TMS-trained technicians have NeuroStar experience. This reduces staffing friction when hiring experienced personnel.

Cons

The pay-per-use business model charges practices $60–$100 per session as a manufacturer fee, which directly reduces practice margins and creates an ongoing financial relationship with Neuronetics. NeuroStar lacks neuronavigation capability, relying instead on landmark-based positioning that some clinicians consider less precise than MRI-guided targeting. The company was notably slow to adopt iTBS protocols compared to competitors like MagVenture.

Pricing

NeuroStar operates on a pay-per-use model with session fees ranging from $60–$100 per treatment, charged separately from the device acquisition cost. Contact Neuronetics directly for current device pricing and leasing terms.

3. BrainsWay

Quick Overview

BrainsWay uses proprietary H-coils (Hesed coils) that deliver what the company markets as "Deep TMS" through diffuse stimulation patterns. The Israel-based manufacturer offers different coil variants for specific indications: H1 for depression, H7 for OCD, and H4 for smoking cessation. BrainsWay received accelerated TMS FDA clearance in September 2025.

Best For

Practices treating diverse patient populations across multiple psychiatric conditions, especially those serving older adults or patients with treatment-resistant presentations. The broad indication set makes BrainsWay attractive for clinics that don't want to limit their referral sources.

Pros

BrainsWay holds the widest FDA indication portfolio, covering major depression, anxious depression, OCD, and smoking cessation. It's the only TMS device cleared for late-life depression in patients aged 22–86, addressing a significant gap in geriatric psychiatry. The recent accelerated TMS clearance positions BrainsWay for the growing demand for compressed treatment protocols.

Cons

H-coils are incompatible with neuronavigation systems by design, limiting targeting precision compared to figure-of-8 alternatives. Because the diffuse stimulation pattern activates a wider area of tissue, it can increase patient discomfort during sessions. BrainsWay operates on an expensive pay-per-use model similar to NeuroStar. The trademarked "Deep TMS" term refers to H-coil stimulation, though H-coils don't penetrate deeper than well-positioned figure-of-8 coils.

Pricing

BrainsWay uses a pay-per-use business model with session fees paid to the manufacturer. Contact BrainsWay directly for device pricing and per-session fee structures, which vary by treatment volume commitments.

4. MagVenture

Quick Overview

MagVenture pioneered commercial TMS in Denmark starting in 1992 and earned the first US iTBS clearance in 2018. The company builds figure-of-8 coil systems with liquid cooling (Cool D-B80 for OCD) that prioritize modularity and research compatibility. MagVenture devices integrate with more neuronavigation platforms than any competitor, which makes them a common choice for academic and research-heavy practices.

Best For

Research-oriented practices or high-volume clinics needing modular coil options and comprehensive neuronavigation compatibility.

Pros

MagVenture earned the first US iTBS clearance in 2018, giving them a two-year head start on accelerated protocols. Liquid cooling enables quiet operation and seamless back-to-back patient scheduling without thermal downtime. The system supports Atlas™, Localite, Brainsight, Vizor2, and Soterix neuronavigation platforms. No other device matches this compatibility range.

Cons

Higher upfront costs hit practices hard, and warranty packages often become expensive upsells during the buying process. Liquid cooling systems demand maintenance vigilance, and cooling failures can sideline the device entirely. The cart-like design consumes more floor space than newer, compact alternatives like Ampa One.

Pricing

MagVenture positions as a premium system with higher upfront costs than most competitors. Contact MagVenture directly for current pricing, since they don't publish rates publicly.

5. Magstim

Quick Overview

Magstim brought TMS therapy to market in 1990, making it the world's first commercial TMS company. The UK-based manufacturer offers air-cooled figure-of-8 coils through their Horizon Performance and newer H3 systems, both paired with StimGuide neuronavigation. FDA clearances cover MDD (both rTMS and iTBS), anxious depression, and OCD.

Best For

Practices wanting navigation capability at a competitive price point without the complexity of MRI-based targeting.

Pros

Magstim's 35-year commercial TMS history provides the deepest field experience of any manufacturer. Air cooling eliminates downtime between patients, since the coil cools fast enough for immediate back-to-back sessions. StimGuide navigation comes included and uses anatomical landmarks rather than requiring MRI uploads, reducing workflow complexity. Clinicians consistently praise the technical support and warranty coverage, and pricing remains competitive against newer entrants.

Cons

The landmark-based StimGuide cannot incorporate patient-specific MRI data for enhanced targeting accuracy. Air cooling systems generate more noise than liquid-cooled alternatives, which some patients find uncomfortable during treatment sessions.

Pricing

Competitive pricing structure with transparent warranty terms. Contact Magstim directly for current device and leasing rates.

TMS Device Comparison Table

  Device Coil Type rTMS iTBS Accelerated TMS Navigation Key Indications Business Model Cost Tier     Ampa One L coil (F8) + M coil (H-style) No ✓ ✓ (ONE-D) Camera-based MDD Leasing only $$   NeuroStar Figure-of-8 ✓ ✓ No Contact Sensing MDD, OCD, anxious depression, adolescent depression Pay-per-use $$$$   BrainsWay H-coil variants ✓ ✓ ✓ (Sept 2025) None MDD, OCD, smoking, late-life depression Pay-per-use $$$$   MagVenture Figure-of-8, liquid-cooled ✓ ✓ No Multiple options MDD, OCD (adjunct) Purchase $$$   Magstim Figure-of-8, air-cooled ✓ ✓ No StimGuide MDD, anxious depression, OCD Purchase $$  

Cost tier: $ = competitive, $$$$ = premium/pay-per-use

As the table shows, no single device wins across all categories. Ampa One's accelerated TMS focus and included navigation make it ideal for modern practices prioritizing workflow efficiency. To see whether Ampa One's streamlined approach fits your clinic's needs, you can request Ampa One leasing information.

Why Ampa One Stands Out for Modern TMS Practices

Ampa One is the only device designed specifically around accelerated TMS, an approach that compresses weeks of treatment into a handful of days. While competitors retrofitted accelerated protocols onto legacy hardware, Ampa One built the ONE-D accelerated protocol into its core design from day one.

The built-in camera-based navigation system eliminates the $20,000–$50,000 add-on cost that other platforms require. Most TMS devices require separate neuronavigation purchases, but Ampa One includes precise coil positioning as standard equipment. This integration reduces both upfront costs and staff training complexity.

Space constraints stop many TMS programs before they start, but Ampa One's near-portable form factor fits into standard exam rooms without the cart-based footprint of traditional systems. Clinics can launch TMS services without dedicated procedure suites or major facility modifications.

The leasing model removes the $150,000+ capital barrier that prevents smaller practices from offering TMS. While some clinicians prefer ownership, the leasing approach makes advanced TMS accessible to psychiatrists who previously couldn't justify the equipment investment. No per-session fees to manufacturers means practices keep their full margin on every treatment.

FAQs

What is a TMS device? A TMS device delivers focused magnetic pulses to targeted brain regions through electromagnetic coils, offering a non-pharmaceutical treatment for conditions like depression and OCD. Ampa One provides this with both focal (L) and diffuse (M) coils in one system. This lets a single device cover multiple stimulation patterns without buying separate equipment.

What is the difference between rTMS and iTBS? rTMS delivers standard protocols lasting 19–37.5 minutes per session. iTBS uses theta burst patterns to achieve the same clinical efficacy in 3-minute sessions. Ampa One received FDA clearance specifically for iTBS protocols and supports the accelerated ONE-D treatment schedule.

Which TMS device has the most FDA clearances? BrainsWay leads with clearances for major depression, anxious depression, OCD, smoking cessation, and late-life depression. NeuroStar adds adolescent depression treatment for patients 15 and older. Ampa One holds clearance for major depression via iTBS, with the ONE-D protocol enabling accelerated treatment schedules.

Do TMS devices require neuronavigation? Navigation improves targeting precision but isn't required for FDA-cleared protocols. NeuroStar and BrainsWay rely on landmark-based coil placement without navigation systems. Ampa One includes camera-based navigation, while MagVenture and Magstim support MRI-based navigation options.

What is the pay-per-use TMS model? NeuroStar and BrainsWay charge practices $60–$100+ per session delivered to the manufacturer. This reduces clinic profit margins and creates an ongoing financial partnership with the device manufacturer. Ampa One uses a leasing model with no per-session fees paid to the manufacturer.

How long does a TMS session take? Standard rTMS sessions run 37.5 minutes, while DASH protocols reduce this to 19 minutes. iTBS protocols complete in 3 minutes per session. Accelerated TMS like ONE-D delivers multiple sessions per day over a compressed timeframe.

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