Understanding FDA not Cleared for Migraine

By TeamCare Sunny Skies - BrainsWay Deep TMS™

Posted: July 10, 2025

Migraine is far more than just a severe headache, it's a complex neurological disorder characterized by recurrent attacks of throbbing pain, typically on one side of the head.

Often accompanied by debilitating symptoms such as nausea, vomiting, and extreme sensitivity to light (photophobia) and sound (phonophobia).

These attacks can last for hours to days and significantly impact an individual's quality of life, leading to missed work, social isolation, and profound distress.

It's estimated that migraines affect over a billion people worldwide, making it one of the most prevalent neurological conditions.

However, a highly relevant article that discusses Deep TMS for Migraine is https://www.brainsway.com/knowledge-center/add-on-deep-transcranial-magnetic-stimulation-dtms-for-the-treatment-of-chronic-migraine-apreliminary-study/

Given its association with abnormal brain activity patterns in regions involved in pain processing and modulation, innovative treatments targeting these neural networks, such as Deep Transcranial Magnetic Stimulation (Deep TMS™), are being explored for their potential effectiveness in managing this chronic condition.

The Deep TMS procedure is performed on an outpatient basis, meaning it does not require hospitalization or anesthesia, making it a convenient option for many.

It typically has minimal systemic side effects, such as mild scalp discomfort or transient headaches, especially when compared to the broader systemic side effect profiles of many oral migraine medications.

However, despite these options, many patients still experience insufficient relief, or they struggle with undesirable side effects such as fatigue, dizziness, or medication overuse headache.

Some concerns exist regarding the long-term effectiveness or tolerability of certain drugs, leading patients to seek alternative or complementary therapies.

In summary

By helping to modulate brain activity, Deep TMS has shown potential in reducing migraine days and severity, translating into fewer missed workdays, improved quality of life, and less reliance on acute medications.

This represents a vital step towards sustained relief and a life where migraines no longer dictate daily existence.

Curious about How BrainsWay Deep TMS® could transform your Health?

BrainsWay Deep TMS® offers innovative approaches not only for neurological and psychiatric conditions.

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Important disclaimer

BrainsWay Deep TMS® Treatment for Migraine is not intended for individuals in the United States as it HAS NOT BEEN FULLY CLEARED by the FDA for safety and efficacy for these specific indications.

"It is important to note that while these specific indications may not be FDA-cleared in the United States, some BrainsWay Deep TMS® treatments for certain conditions may have received CE Mark approval in Europe, indicating compliance with European health, safety, and environmental protection standards. Always verify the regulatory status of any treatment in your specific region."

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