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

Five TMS devices hold FDA clearance in the United States, and choosing among them comes down to matching a device to your practice's indication mix, patient volume, and financial model. This comparison evaluates all five against the same clinical and business criteria. No device wins every category. Each carries trade-offs that land differently depending on how your practice runs.

Clinicians weigh these devices on coil type (figure-of-8 versus H-coil), treatment protocol (standard rTMS versus 3-minute iTBS), neuronavigation, and how transparent the business model is. Patients want to know which device treats their condition most effectively. Practices need to know which one fits their workflow and margin structure. This guide answers both.

What Is TMS?

Transcranial magnetic stimulation (TMS) delivers focused magnetic pulses to targeted brain regions through the skull, with no surgery and no anesthesia. The magnetic field temporarily changes neural activity in specific cortical areas, giving patients a non-pharmaceutical treatment for psychiatric conditions such as depression and OCD.

Every TMS system has three core parts: a magnetic stimulator that generates the pulses, a coil that focuses the field, and a positioning system that targets the correct brain region. The stimulator produces brief, powerful pulses up to 2 Tesla. The coil shapes and directs that energy roughly 2–3 centimeters into brain tissue.

Two coil families dominate the market. Figure-of-8 coils create focal stimulation in a concentrated area about the size of a quarter. H-coils produce more diffuse stimulation across wider regions with less precision. BrainsWay markets its H-coil approach as "Deep TMS," but both coil types penetrate similar depths. The real distinction is stimulation breadth, not depth.

Three protocols define modern TMS delivery. Standard rTMS delivers 10 Hz pulses over 37.5 minutes per session. iTBS (intermittent theta burst stimulation) compresses an equivalent therapeutic dose into 3-minute sessions. Accelerated protocols such as ONE-D deliver multiple daily sessions over a compressed timeframe, rather than spreading treatment across 6–8 weeks.

FDA clearance is granted indication by indication. Each psychiatric condition requires its own approval, and no single device is cleared for every indication. That is why the right device depends on your patient population and treatment goals.

How We Evaluated These Devices

We compare each device across seven criteria that directly shape clinical practice and patient outcomes. FDA clearance breadth determines which conditions you can treat, since approved indications differ by device. Coil type and stimulation parameters affect precision: figure-of-8 coils stimulate focally, while H-coils cover a wider, more diffuse area.

Treatment protocol and session length drive the biggest workflow differences. Standard rTMS runs 37.5 minutes per session; iTBS runs 3 minutes, a decisive efficiency factor for high-volume practices.

Neuronavigation ranges from none (NeuroStar, BrainsWay), to an included camera system (Ampa One), to MRI-compatible options (MagVenture). Business models vary just as widely: outright purchase, leasing, or pay-per-use arrangements that charge the manufacturer $60–$100 per session. We also weigh ease of use, technical support, and warranty terms, all of which shape long-term operating cost.

1. Ampa One

Ampa One enters the market as a US-based startup with a clinician-designed system built around workflow efficiency. It offers two coils: the L coil (focal stimulation, equivalent to figure-of-8) and the M coil (diffuse stimulation, comparable to H-coil technology). The L coil holds FDA clearance through the iTBS protocol, positioning Ampa One around faster treatment delivery rather than traditional rTMS. The system includes camera-based navigation with no additional hardware cost and is built around the ONE-D accelerated protocol, making it the only device purpose-engineered for that compressed timeline.

Best for. Practices that want accelerated TMS as their primary approach, and clinics that want simpler workflows and less session complexity.

Pros. Ampa One is the only TMS system built specifically for ONE-D accelerated protocols from the ground up. Integrated camera-based navigation removes the add-on cost that other devices charge for precise targeting. Two coils, focal (L) and diffuse (M), let a practice address different stimulation needs without buying separate systems. The compact, nearly portable design needs less space than cart-based systems, and clinicians report shorter training curves thanks to the simplified interface. iTBS clearance enables 3-minute sessions rather than the 19–37.5 minute protocols older systems require.

Cons. As a newer entrant, Ampa One lacks the extensive usage history that older manufacturers can point to.

Pricing. Ampa One operates exclusively on a leasing model: $3,000/month month-to-month, or $2,700/month on an annual lease. Once the lease is in place, the practice pays no per-session, coil replacement, or upgrade fees.

2. NeuroStar (by Neuronetics)

NeuroStar was the first FDA-cleared TMS device in the United States, approved in 2008. It 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 holds the largest US market share and has accumulated extensive outcomes data through its NeuroStar Advanced Therapy registry. The device uses Contact Sensing technology to verify coil placement rather than neuronavigation, prioritizing consistency with anatomical landmarks over individualized MRI-based targeting.

Best for. Practices that prioritize established clinical evidence and broad manufacturer support, and clinics that want the confidence of the largest installed base and most extensive outcomes tracking in American TMS.

Pros. NeuroStar offers a broad FDA clearance portfolio covering major depressive disorder, OCD, anxious depression, and adolescent depression for patients 15 and older. It benefits from long-window clinical validation across thousands of treatments and a large outcomes registry. Neuronetics provides thorough training and the most established support infrastructure in US TMS. Because of its early market entry, most TMS-trained technicians already have NeuroStar experience, which reduces staffing friction when hiring.

Cons. The pay-per-use model charges practices $60–$100 per session as a manufacturer fee, directly reducing margin and creating an ongoing financial relationship with Neuronetics. NeuroStar lacks neuronavigation, relying on landmark-based positioning that some clinicians consider less precise than MRI-guided targeting. The company was also relatively slow to adopt iTBS compared with competitors like MagVenture.

Pricing. Pay-per-use, with session fees of $60–$100 charged separately from device acquisition. Contact Neuronetics directly for current device pricing and leasing terms.

3. BrainsWay

BrainsWay uses proprietary H-coils (Hesed coils) that deliver what the company markets as "Deep TMS" through diffuse stimulation. The Israel-based manufacturer offers 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 populations across multiple psychiatric conditions, especially those serving older adults or patients with treatment-resistant presentations. The broad indication set suits 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 is the only TMS device cleared for late-life depression in patients aged 22–86, addressing a real gap in geriatric psychiatry. The recent accelerated TMS clearance positions BrainsWay for growing demand for compressed protocols.

Cons. H-coils are incompatible with neuronavigation by design, which limits targeting precision compared with figure-of-8 alternatives. Because the diffuse pattern activates a wider area of tissue, it can increase patient discomfort during sessions. BrainsWay runs an expensive pay-per-use model similar to NeuroStar. And while "Deep TMS" is trademarked, H-coils do not penetrate deeper than well-positioned figure-of-8 coils.

Pricing. Pay-per-use, with session fees paid to the manufacturer that vary by treatment-volume commitment. Contact BrainsWay directly for device pricing and per-session structures.

4. MagVenture

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

Best for. Research-oriented practices or high-volume clinics that need modular coil options and comprehensive neuronavigation compatibility.

Pros. MagVenture's 2018 iTBS clearance gave it a two-year head start on accelerated protocols. Liquid cooling enables quiet operation and back-to-back scheduling without thermal downtime. The system supports Atlas, Localite, Brainsight, Vizor2, and Soterix neuronavigation platforms, a compatibility range no other device matches.

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

Pricing. A premium system with higher upfront costs than most competitors. MagVenture does not publish rates publicly; contact the company directly for current pricing.

5. Magstim

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 its 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 that want navigation capability at a competitive price point without the complexity of MRI-based targeting.

Pros. Magstim's 35-year commercial TMS history gives it 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 MRI uploads, which reduces workflow complexity. Clinicians consistently praise the technical support and warranty coverage, and pricing stays competitive against newer entrants.

Cons. Landmark-based StimGuide cannot incorporate patient-specific MRI data for enhanced targeting accuracy. Air cooling also generates more noise than liquid-cooled alternatives, which some patients find uncomfortable during sessions.

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

The Bottom Line

No single device wins across every category. NeuroStar and BrainsWay bring the broadest clearances and the deepest outcomes data, but tie your margin to per-session manufacturer fees. MagVenture and Magstim offer strong navigation and research flexibility at a higher upfront or space cost. Ampa One's accelerated-TMS focus, included navigation, and no per-session fees make it well suited to modern practices built around workflow efficiency. To see whether Ampa One's streamlined approach fits your clinic, you can get in touch with our sales team.

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 removes the $20,000–$50,000 add-on cost that other platforms require. Most TMS devices need a separate neuronavigation purchase; Ampa One includes precise coil positioning as standard equipment, which lowers both upfront cost and training complexity.

Space stops many TMS programs before they start. Ampa One's near-portable form factor fits into a standard exam room without the footprint of a cart-based system, so clinics can launch TMS services without dedicated procedure suites or major facility changes.

The leasing model removes the $150,000+ capital barrier that keeps smaller practices out of TMS. Some clinicians will always prefer ownership, but leasing makes advanced TMS accessible to psychiatrists who previously could not justify the investment, and no per-session fees means practices keep their full margin on every treatment.

Frequently Asked Questions

What is TMS? Transcranial magnetic stimulation delivers focused magnetic pulses to targeted brain regions through electromagnetic coils, offering a non-pharmaceutical treatment for conditions such as depression and OCD. Ampa One provides this with both focal (L) and diffuse (M) coils in one system, so a single device covers 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 comparable clinical efficacy in 3-minute sessions. Ampa One is FDA-cleared specifically for iTBS 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 for patients 15 and older. Ampa One holds clearance for major depression via iTBS, with the ONE-D protocol enabling accelerated schedules.

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

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

How long does a TMS session take? Standard rTMS runs 37.5 minutes, DASH reduces it to 19 minutes, and iTBS completes in 3 minutes per session. Accelerated TMS such as ONE-D delivers multiple sessions per day over a compressed timeframe.