When considering the many treatment options available for major depressive disorder or other mood disorders, it is important to choose therapies that are effective and medically condoned by regulatory bodies, in the United States, the most important of these is the U.S. Food and Drug Administration (FDA). In fact, our patients frequently ask, “Is the NeuroStar TMS therapy system FDA cleared?”
The answer is yes, NeuroStar is an FDA-cleared transcranial magnetic stimulation (TMS) device for treating major depressive disorder and other qualifying conditions. So, why does this matter? Understanding a therapy’s approval status can help you make informed decisions about your mental health care and choose treatments that are certified to be safe and effective. At Synergy Strive, we use NeuroStar because it meets the rigorous safety and effectiveness standards set out by the FDA, this is just one of the reasons why it is considered the #1 physician-recommended TMS treatment.
The FDA clears medical technologies based on safety, clinical evidence, and overall therapeutic benefit. NeuroStar TMS received FDA clearance in 2008 for major depressive disorder treatment in adults who had not responded to at least one antidepressant medication. It was one of the first TMS therapies to achieve this clearance. NeuroStar’s FDA clearance was based on 65 controlled clinical trials, including 100,000 participants, which proved its effectiveness in reducing depression symptoms. During these studies, patients who received TMS treatment with the NeuroStar device showed significant improvements in mood and daily functioning compared to those who received placebo treatments.
NeuroStar’s FDA clearance also reflects the device’s strong safety profile, with most patients experiencing only mild, short-term side effects, such as scalp discomfort or headaches. FDA clearance does not just confirm the treatment works, it also confirms that it operates in a safe, controlled manner. This makes NeuroStar a trustworthy option for patients and providers alike.
You may be wondering if FDA clearance covers other conditions beyond depression for NeuroStar TMS therapy. The FDA has since expanded NeuroStar’s clearance to include treating obsessive-compulsive disorder as part of an adjunctive therapy plan. This highlights the device’s adaptability and continued evaluation by regulatory authorities.
At Synergy Strive, we stay apprised of clinical science to ensure you receive the most effective care. Your provider will determine whether NeuroStar is a good fit for your specific needs based on your diagnosis, symptoms, and previous treatment history. Knowing that the FDA has thoroughly reviewed and cleared NeuroStar helps build confidence in starting this TMS therapy. We believe in using studied, data-backed technologies to help you move forward with your treatment.
Now that you know the answer to “Is the NeuroStar TMS therapy system FDA cleared?” you can feel more confident considering this innovative treatment for your needs. We proudly offer NeuroStar at Synergy Strive as one of the foundations of our comprehensive mental health services because it meets FDA standards of safety and clinical effectiveness.
You deserve a solution that is both scientifically supported and uniquely designed for your personal needs. Contact our team today to arrange an appointment and find out whether NeuroStar TMS therapy is right for you.
