TMS Devices Review

Neuronetics make NeuroStar TMS. Neuronetics was created in 2003 and funded the pilot studies that came up with the conventional 10 Hz TMS therapy protocol as we know it today. Neuronetics sponsored the main pivotal trial published in Dec 2007 and got the first FDA clearance for TMS therapy in 2008. This makes NeuroStar the first FDA-cleared TMS in the USA market. Because of their original patent in the US, they were the only player in the US market for a while. This explains their penetration in the TMS market. Please note that Neuronetics didn’t invent TMS. TMS was developed in Europe, not in the US. 

NeuroStar Advanced Therapy uses a figure-of- 8 coil. The NeuroStar system can do standard, 37.5 minutes per session; DASH, 19 minutes per session and TouchStar™ Theta Burst, which is simply iTBS protocol. NeuroStar came late to adopt Theta Burst Stimulation technology. NeuroStar resisted iTBS for a while before finally accepting reality. NeuroStar doesn’t have a navigation system to ensure the placement of the coil. Instead, NeuroStar has a "Contact Sensing" that will alert the treater if contact was lost. They have other fancy trademarks for gimmicks like D-Tect™ which helps the operator "detect" thumb/hand movement during MT determination. Neuronetics has a pay-per-use business model, meaning the TMS clinic has to pay a fee for every TMS session. This, in my opinion, is a poor business model that doesn't serve physicians and patients.

In addition depression treatment for adults, NeuroStar is FDA cleared for treating OCD and anxious depression. Also, most recently it got FDA-cleared for depression in adolescents. NeuroStar aligned their name with an advocacy that resulted in an inappropriate Medicare policy allowing nurse practitioners to manage TRD with TMS. A subspeciality outside the scope of practice for midlevel providers.

Pros:

• Good market penetration. 
• Good support and training. 

Cons:

• Little late to the iTBS party.
• The pay-per-use business model makes them a “silent partner” with the TMS practice.
• The website directory favors some clinics over others.
• Aggressive advocacy at the FDA and insurance companies. Producing bizarre clearance of F8 coil for OCD.
  

BrainsWay

BrainsWay is based in Israel but do most of their clinical work in the USA. BrainsWay TMS devices use Hesel coils. An H coil stimulates deeper in the brain but that comes at the expense of focality. This had been described as “Deep TMS”. The terminology dTMS is not restricted to Hesel coils. It also describes dTMS induced by double cone coils and Halo-circular assembly (HCA) coils. BrainsWay has a patent or a trademark on the terminology deep TMS, which is a descriptive terminology. Any coil can be large enough and powered enough to stimulate deeply. A better description of their product is; non-focal TMS of diffuse-TMS. For this reason, I am calling their H coil dTMS diffuse-TMS.

The main proposal for dTMS is stimulation larger area of the brain cortex. This could increase the chances of “hitting the correct target.” But also, It means delivering a diffuse magnetic field. Often this results in more discomfort during the treatment and, possibly (for the H1 coil), a higher risk of seizure compared to the focal TMS treatment with the figure-of-8 coil. BrainsWay is also FDA cleared for iTBS. H coils are incompatible with any navigation systems. For an obvious reason, there is no point in using navigation for targeted treatment when the coil is stimulating broadly. 

BrainsWay H1 coil is FDA-cleared for Treatment Resistant Depression and for anxiety associated with depression. BrainsWay H7-coil FDA-cleared for OCD and MDD. BrainsWay H4 coil is FDA-cleared for smoking cessation. It is interesting how close the H7 and H4 coils are in design and function. Their FDA-clearance paperwork presented the H4 coil as substantially equivalent to the H7 coil. The H4 coil was a 510(k) clearance, not a de novo clearance. Feel free to read the FDA document here and make your own conclusions. Another example of BrainsWay's attempts to reinvent the wheel would be their future H8 coil. It failed to show good results for alcohol use disorder. Hence, they are going back to see if H7 would do the trick. Lastly, they spend a lot of money to market superiority, like marketing a foreign paper showing that their H1 coil is better than the F8 coil when there was no difference in remission. Recent data shared during the CTMSS 2022 from US-based clinics didn't show the superiority of dTMS.

Pros:

• Innovative and research-driven.
• Good support and training.
• Indications for MDD + Anxiety, OCD, and Smoking Cessation.

Cons:

• Expensive.
• Superiority complex.
• It might be less tolerable for some patients.

MagVenture is one of the two major pioneers of TMS in Europe (the other one being MagStim). They are based in Denmark. They are proud of the modularity of their system. They have many coils that serve the purpose of research. MagVita is FDA-cleared for rTMS and iTBS. They are the first ones to get the iTBS clearance in 2018. They are now offering a neuronavigation system called Atlas. MagVenture Atlas™ Neuro Navigation System got an FDA clearance in March 2023. Also, you can also add your own neuronavigation system from Brainsight, Localite, Vizor2 or Soterix. MagVenture also collaborated with Axilum for a robotic arm. The robotic arm automatically changes the coil’s position based on patient movements and input from a navigation system.

MagVenture Cool D-B80 coil got a 510(k) FDA-clearance in 2020 for adjunctive treatment of OCD. MagVenture is the second of many TMS manufacturers to offer an OCD treatment after BrainsWay, followed by NeuroStar and Magstim. That being said the H7 coil and D-B80 are legit in their design to match the work that showed efficacy. The F8 coil clearance of NeuroStar and MagStim was a stretch, to say the least!

MagVenture uses a liquid cooling system. This makes it very fast to cool the coil, treating patients back to back throughout the day. It is also quieter than air-cooled systems. Liquid cooling and electrical components are not exactly the best combo. You have to be vigilant with maintenance.

Pros:

• Reliable, versatile, and reasonably priced.
• Good support.
• MDD and OCD coils.

Cons:

• Aesthetically ugly, cart-like design.
• Warranties can be expensive upsells.

Apollo TMS is a product of Mag & More. They are based in Germany. They make fashionable designs for the TMS machine and the TMS chair. They make a unique coil stabilization unit called HANS. The HANS (Head-And-Neck-Support) positioning system ensures that you are reproducibly stimulating the correct treatment spot by following head movement. HANS is good on paper but not very practical in real life. That being said, they offer alternatives to how you can mount the coil. Apollo is FDA-cleared for both rTMS and iTBS.

Apollo uses a unique coating cooling system to cool the coil between sessions. This makes the coil very quiet. This cooling method is not very practical for having multiple back-to-back sessions. Recently, they added an air cooling add-on function to their coil, which seems to cool it faster. Neurocare took over the distribution and support of the Apollo system. They improved support, fixed some apparent flaws, and added air cooling and a new robust chair. These improvements came with an expense passed on to the consumer by increasing the system's list price and warranty. Apollo has the shortest pulse width of any TMS device. The narrower the pulse width, the more potentiating it can be from the neurobiology standpoint. That finding is not proven to be clinically relevant except in the patient's sense of pain or discomfort during treatment. Neurocare group manages its own clinics and is expanding. They have strong ties with Brainclinics Foundation internationally. The Brainsclinics approach for Neurocardiac-guided TMS, in particular, is auspicious.

Pros:

• Aesthetically pleasing modern design.
• Reasonably priced.
• Quiet.

Cons:

• Afterthought cooling system.

Ultimate rTMS is a product of Brain Ultimate. The device is manufactured in China by Yingchi TMS. Ultimate rTMS was selling for while but just recently got an FDA clearance for MDD. I had a virtual demo of the device, so my opinion might change when I use it in-person. It uses an F8 coil that is liquid cooled (water cooled). Also, their clearance also has an air cooled coil. So they basically have two different F8 coils and both can be sold in the US. They are proposing a double cone coil for OCD but no FDA clearance yet for the OCD one. Ultimate TMS can do both rTMS and iTBS. But currently, Ultimate is FDA cleared for 10 Hz rTMS only.

The system is affordable and modular enough for practicality. This comes at the expense of looking like a crash cart. Ultimate TMS and Cloud TMS are basically taking the same approach to providing off the shelf generic TMS. I give the edge to Ultimate for having superior communication.

Pros:

• Modular design.
• Good value.

Cons:

• Only 10 Hz protocol FDA clearance for MDD despite the device capability of iTBS.
• The crash cart look!

Blossom TMS is a product of Sebers Medical. They are in the US as a branch of a parent company in Germany. The device is manufactured in South Korea. Blossom TMS is the new kid on the block. I had a virtual demo of the device, so my opinion will probably mature once I have hands-on experience with it. It looks aesthetically pleasing. It uses an F8 coil that is oil cooled, which means effective cooling and relatively quiet stimulation. The coil is permanently attached to the stimulator structure. This means less risk of leaks and potential low maintenance. On the other hand, it means you can’t add different coils for other indications. Blossom can do both rTMS and iTBS. But currently, Blossom is FDA cleared for 10 Hz rTMS only. I understand that they are working on another upgraded TMS system with more indications.

The chair is very promising. It has a massage function and a unique, comfortable “head nest” to stabilize the patient's head during TMS treatment. The unit is very portable. It plugs into a 110-volt outlet. The system is affordable with the best value for the money I have seen so far.

Pros:

• Beautiful design.
• Great value.
• Quit.

Cons:

• Only 10 Hz protocol FDA clearance for MDD despite the device capability of iTBS.
• A new company, so reliability and support are to be seen.
  

Another innovative TMS company. NexStim is based in Finland. SmartFocus by Nexstim was originally made to help Neurosurgeons with brain mapping before performing brain surgery. They brought their TMS system to the US market for depression therapy. NexStim TMS is capable of rTMS, iTBS, and neuronavigation TMS which they call NBT Navigated Brain Therapy. 

SmartFocus requires a specific structural MRI of the brain for the system for the neuronavigation function to be enabled. Getting an MRI is not a medical necessity, neither for depression nor TMS. Therefore, insurance may not pay for the MRI portion of the treatment plan, so the patient will have to pay out of pocket for the MRI, or the TMS clinic has to eat the cost of such an MRI. Furthermore, this MRI navigation requires the inconvenience of sending the patient to an imaging center to get a brain MRI. Sadly, they don't have a clear business model of how they want to sell their system to doctors. They say it is not a pay-per-use model, but you have to buy the disposable head trackers from them for every TMS session you do. That is technically a pay-per-use model!

Magnus Medical made a multimillion dollars deal with NexStim to license their Neuronavigation technology for the upcoming SAINT-capable TMS device.

Pros:

• Cutting-edge NeuroNavigation technology.
• Very well-made system.

Cons:

• Needs an MRI. No option to upload an MNI Average Brain MRI.
• The disposable head tracker fee is a walk around the pay-per-use model.

I use MagStim in my practice. MagStim is based in the UK. Dr. Anthony Parker pioneered the first TMS machine in the UK in 1985. In 1990 MagStim parent company made TMS commercially available. Horizon Performance with Stim-Guide is FDA-cleared for rTMS, iTBS and navigated TMS. Stim-Guide is their version of neuronavigation. StimGuide doesn’t require an MRI to guide the operator to the treatment location. Non-MRI-guided targeting is less accurate than structural MRI-guided targeting, and structural MRI-guided targeting is less accurate than functional connectivity MRI targeting. Read my detailed article about navigated TMS if you are interested in learning more about navigated TMS.

MagStim uses an air cooling system. This makes cooling the coil very fast. We never encountered downtime between patients to cool the system. The caveat to air cooling is that it makes the system loud because of the cooling fans.

H3 is their updated TMS system. It builds on the sound foundations of Horizon Performance with StimGuide but adds a better user interface software. Recently in Jan 2023, H3 gained clearance for OCD, and in March 2023 got clearance for anxious depression.

Pros:

• Reliable, versatile, and reasonably priced.
• Excellent technical support and warranty.
• Navigation system.

Cons:

• Unable to upload a patient’s MRI or an MNI Average Brain MRI to improve the navigation accuracy.
• Loud cooling system.

Magnus Medical got an FDA-clearance for SAINT TMS protocol. In my opinion, minus the functional connectivity MRI targeting, Accelerated Intermittent Theta Burst Stimulation is the future of TMS. As you are probably aware, SAINT coupled aiTBS with individualized fcMRI targeting the functional DLPFC (the most anticorrelated PFC to the sgACC). Magnus Medical is a new startup that licensed this intellectual property to bring this SAINT protocol to the market. I haven't seen the device yet. Magnus Medical as a company is a huge disappointment. Magnus created a monopoly on accelerated TMS without actually producing the device. The fcMRI component of the SAINT is questionable clinically and might be serving the patent rather than the patient. If Magnus didn't exist, thousands of patients would have received aiTBS at an affordable cost and dare I say, some lives would have been saved!

NeuroQore is the newest company to get an FDA clearance for a TMS device. I haven' seen the actual device yet.

Cloud TMS is not on my recommended TMS devices list. Please don't contact me asking why I dropped Cloud TMS, contact Cloud TMS and ask them why!