TMS is FDA Approval

What Does It Mean That “TMS Is FDA-Approved”

TMS Is FDA Approved

FDA approval is a big step for any treatment or medication that comes to market. Not all treatments receive this approval — it’s not just a rubber stamp. Before new medical products and devices can be widely used or imported, the Food and Drug Administration takes time to evaluate their benefits and potential dangers. The purpose of this approval process is to ensure that all medications, treatments, and procedures available to the public are effective and safe. “Safe” can sometimes be a relative term when it comes to medicine — almost any drug can cause harm in excessive doses, for example — but in order to gain FDA approval, a new medical advancement should have benefits that far outweigh the risks when used appropriately. Medical and food products receive this extra level of scrutiny, compared with other consumer products, because they interact directly with consumers’ bodies and, in the case of TMS and other mental health treatments, with their brains. It’s vital that such products be held to the highest of quality standards. That’s why it’s so significant that TMS is FDA approved.

Even with FDA approval, people are often hesitant to try a treatment method that is new to market. For obvious reasons, not many people are interested in being the first to try something that alters the way their brain functions. However, while it is still not as well-known as many other mental health treatments, TMS received FDA approval over a decade ago. Since 2008, TMS machines have been in use treating a wide range of psychological disorders, including major depressive disorder, obsessive-compulsive disorder and other anxiety disorders, and bipolar disorder. 

The FDA Approval Process

After analyzing the results of clinical trials, the FDA will typically first approve a medicine or a device for a specific and narrow focus called an “indication.” In the case of the first TMS machines, the approved indication was major depressive disorder. After that first approval has been granted, another trial or series of trials may be conducted to broaden the approved application of the device or medication to include other indications. Since TMS’s initial approval as a major depression treatment, a variety of TMS machines have gained FDA approval for the treatment of other mental health conditions, such as obsessive-compulsive disorder. TMS machine manufacturers are currently conducting further studies into still other applications, including postpartum depression. So, while TMS is FDA approved for a broad range of depression and anxiety-related disorders already, there is a good chance that this technology still has a great deal more to offer. Clinical trials will continue, and as the results of these trials are published, it is plausible that TMS will be FDA approved for more and more psychological disorders. 

What TMS FDA Approval Means for Consumers

When any new treatment appears on the market, the confidence that patients and healthcare providers place in that treatment usually has a lot to do with FDA approval. FDA approval is how you can be sure that a device has been thoroughly tested and reviewed, and has proven not only safe but also effective in treating the particular indication or indications it was tested for. TMS patients are typically struggling with treatment-resistant psychological conditions, so establishing confidence in a treatment can be especially crucial and challenging. In order to get the most out of treatment, it’s important to be able to relax, be present, and focus on achieving symptom remission. Nobody should have to worry about the safety and effectiveness of the technology being used to help with their recovery. 

Transcranial magnetic stimulation is a technology that has been around for over a decade. Since the Neurostar TMS machine received its FDA approval in 2008, several other TMS machines from other manufacturers have received approval for a range of applications. Variations on TMS therapy have also been developed to address the needs of patients with different conditions. Some of these approved machines are built to administer repetitive TMS (rTMS), others to administer deep TMS (dTMS). 

Today, TMS technology is a tried and true method of addressing the symptoms of psychological disorders and helping patients achieve symptom remission where medication and traditional therapy have fallen short. When used as a major element of a comprehensive treatment strategy, TMS is a powerful tool in the fight against psychological illness. While TMS is FDA approved for the indications already discussed, namely, depressive, anxiety, and bipolar disorders, more applications are constantly being studied. Perhaps in the coming years, TMS will be FDA approved for the treatment of an even great variety of psychological issues. 

So in the end, what does FDA approval really mean? It should mean that you, as the consumer, can have some peace of mind when considering TMS as a treatment option for your depression, anxiety, OCD, or bipolar symptoms. It means that, if medication and therapy have not been enough, and your doctor thinks that TMS is the next step in addressing your psychological disorder, you can approach TMS treatment with confidence.

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