FDA Clears Magstim Transcranial Magnetic Stimulation System for U.S. Adolescent Patient Treatment

Adolescent patients ages 15-21 can now receive non-invasive TMS for treatment of major depressive disorder (MDD)*

MINNEAPOLIS, March 19, 2025 (GLOBE NEWSWIRE) -- Major depression impacts more than 5 million U.S. adolescents every year, and NIH data shows that 20% of those aged 12 to 16 have had at least one major depressive episode*. The FDA has now cleared the Magstim Horizon 3.0 and Inspire Transcranial Magnetic Stimulation Systems for treating adolescent patients aged 15-21 for MDD, providing a non-invasive, non-pharmacological technology to improve care.

“For adolescents struggling with depression, treatment options like antidepressants may not work for or be wanted by all patients,” said Dr. Eric Robbins, Blue Umbrella Psychiatry. “TMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of MDD. TMS technology has helped our adult patients improve their quality of life and we are excited to offer this for our adolescent patients.”

This FDA clearance for the Magstim Horizon 3.0 and Inspire systems builds on the existing patient TMS clearances for adult patients, making it possible for physicians and nurse practitioners to treat adolescent patients and gain authorization from insurance providers.

According to the WHO, adolescence is a crucial period for development, and untreated depression is a leading cause for illness and disability*.

“Adolescents and the health professionals who care for them need support, innovation and tools to treat depression,” said Ronnie Stolec-Campo, CEO, Magstim. “Through this FDA approval, thousands of adolescent patients with depression will be able to take advantage of our nonpharmacologic advanced technology. Magstim is now the only TMS system which can treat MDD, Anxious Depression, OCD, and Adolescent Depression with a single treatment coil.”

Practices with current Magstim Horizon systems can begin treating adolescents immediately, following standard patient care protocols.

TMS is a safe and well tolerated treatment that is not associated with any of the systemic side effects typically experienced with antidepressants.

Practices in the USA using the Horizon 3.0 system have delivered over Four Hundred Million treatment pulses to address patient mental health. Magstim developed the first TMS system more than 30 years ago; over 16,000 studies published worldwide cite the use of Magstim stimulators.

*NIH Source: https://www.nimh.nih.gov/health/statistics/major-depression

*WHO Source: https://www.who.int/news-room/fact-sheets/detail/adolescent-mental-health

*Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21)

To learn more about Magstim Horizon and the entire family of research and clinical neurotechnology innovations, visit Magstim.com or call 844-624-7846.

About Welcony

Globally, Welcony technologies have supported thousands of research labs, clinics, hospitals and universities that focus on mental health, brain disorders, cognitive neuroscience and neuromonitoring. Key brands include Magstim Magnetic Stimulation, MagstimEGI high-density EEG, Technomed Clinical Neurophysiology and Neurosign Interoperative Nerve Monitoring. Welcony is backed by Telegraph Hill Partners, a San Francisco based private equity company.

CONTACT: Media Contact: Mark Sejvar, mark.sejvar@magstimegi.com, 323-363-3530