{"id":27398,"date":"2025-08-25T03:43:17","date_gmt":"2025-08-25T03:43:17","guid":{"rendered":"https:\/\/magventure.com\/us\/?p=27398"},"modified":"2025-08-29T16:39:33","modified_gmt":"2025-08-29T16:39:33","slug":"fda-clearance-to-expand-tms-therapy-indication-for-adolescents-aged-15-21","status":"publish","type":"post","link":"https:\/\/magventure.com\/us\/fda-clearance-to-expand-tms-therapy-indication-for-adolescents-aged-15-21\/","title":{"rendered":"FDA Clearance to Expand TMS Therapy Indication for Adolescents Aged 15\u201321"},"content":{"rendered":"
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\n \n \n News\n<\/p>\n <\/div>\n

August 25th 2025<\/p>\n <\/div>\n

FDA Clearance to Expand TMS Therapy Indication for Adolescents Aged 15\u201321<\/h1>\n <\/div>\n
\n \"FDA\n <\/div>\n <\/div>\n <\/div>\n<\/section>\n\n\n\n
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MagVenture Receives FDA Clearance to Expand TMS Therapy Indication for Adolescents Aged 15\u201321<\/strong><\/p>\n\n\n\n

Alpharetta, GA \u2014 August 25, 2025<\/p>\n\n\n\n

MagVenture, the global leader of non-invasive TMS neuromodulation technology, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for an expanded indication of its MagVenture TMS Therapy\u2122 system. The system is now indicated as an adjunct treatment for Major Depressive Disorder (MDD) in adolescent patients aged 15 to 21 who have not responded adequately to prior antidepressant medication.<\/p>\n\n\n\n

This clearance allows U.S.-based providers using MagVenture systems to now offer this safe, effective, and non-pharmacological therapy to adolescent patients, supporting a growing clinical demand for alternative depression treatments in younger populations.<\/p>\n\n\n\n

Up to 20% of adolescents will have a major depressive episode before adulthood, meaning that the mental health needs of this demographic are both urgent and complex. Many teens face barriers to sustained medication use, with non-compliance rates up to 60%, making alternative treatment options increasingly relevant.<\/p>\n\n\n\n

MagVenture TMS Therapy utilizes magnetic pulses generated by MagVenture\u2019s liquid-cooled treatment coils to stimulate neurons in areas of the brain associated with depression, including the left dorsolateral prefrontal cortex (DLPFC). This region is closely linked with mood regulation. TMS is a noninvasive procedure and does not require anesthesia or systemic medication. Each session typically lasts about 20 minutes and can be seamlessly integrated into a patient\u2019s weekly schedule without the need for recovery time.<\/p>\n\n\n\n

For adolescent patients, the clinical promise of TMS is significant. Treatment benefits may last up to six months, offering patients and their families a meaningful window of symptom relief and recovery.<\/p>\n\n\n\n

Payers continue to expand coverage of TMS for adolescent patients aged 15-21 with Major Depressive Disorder (MDD). It is covered by many major insurers, including Humana, Aetna, Cigna (Evernorth), Health Care Service Corporation, BlueCross BlueShield of North Carolina, BlueCross BlueShield of Michigan, and some state Medicaid programs, including California Medi-Cal.<\/p>\n\n\n\n

Martha Koo, M.D., Chief Medical Officer of Your Behavioral Health and Neuro Wellness Spa and immediate past President of the Clinical TMS Society, commented, \u201cMany of our adolescent patients arrive feeling hopeless- believing they\u2019ve exhausted treatment options and will never again enjoy friends, hobbies, or school. With MagVenture TMS Therapy, we\u2019ve been able to offer a noninvasive approach that resonates with teens and their families and gets results. We\u2019ve observed sustained improvements in mood and function, especially in those who were previously medication non-compliant.\u201d Dr. Koo will lead an educational webinar on September 17th, 2025, at 8:00 am Pacific Time\/11:00 am Eastern Time<\/strong> for providers to learn more about using TMS to treat younger patients with depression.<\/p>\n\n\n\n

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Register Here<\/a><\/div>\n<\/div>\n\n\n\n

TMS therapy is considered safe and effective for adolescent use, with the most commonly reported side effect being temporary discomfort at or near the treatment site, usually occurring early in the treatment course. Overall, MagVenture TMS Therapy has demonstrated a favorable safety profile and offers a viable adjunctive treatment for adolescents with MDD who may not benefit from or cannot tolerate pharmacologic therapies alone.<\/p>\n\n\n\n

MagVenture has also recently cleared the T65 coil<\/a> that be used for treatment of MDD. T65 coil\u2014MagVenture\u2019s lightest cooled coil\u2014combines the functionality of the C-B60 and Cool-B65 into a single solution for both motor threshold measurement and treatment. With a lighter-weight, quieter performance, quick-connect design, and longer lifetime, the T65 is engineered to reduce operator fatigue, improve the patient experience, and increase workflow efficiency while maintaining the proven magnetic field properties of the Cool-B65.<\/p>\n\n\n\n

Kerry Rome, Senior Vice President of MagVenture Inc., noted that these regulatory milestones reinforce the company\u2019s broader commitment to innovation and access. \u201cThis expanded FDA indication and introduction of the T65 coil advance our mission to make effective, non-invasive treatment accessible to more patients. We strive to support clinicians with technologies that are grounded in evidence, adaptable in practice, and driven by real patient needs.\u201d<\/p>\n\n\n\n

MagVenture\u2019s TMS systems are widely used across academic institutions, private clinics, and hospital networks, with a reputation for precision engineering, flexible protocols, and integrated safety features. The addition of the adolescent indication enables current and new MagVenture customers to meet the needs of a growing patient group with confidence and continuity of care.<\/p>\n\n\n\n

About MagVenture<\/strong><\/p>\n\n\n\n

MagVenture develops and manufactures non-invasive magnetic stimulation systems used globally in psychiatry, neurophysiology, neurology, cognitive neuroscience, rehabilitation, and pain management. With over three decades of experience in the field, the company is committed to delivering safe, effective, and future-facing treatment technologies that empower healthcare professionals and support better outcomes for patients of all ages.<\/p>\n\n\n\n

Media inquiries:<\/strong><\/p>\n\n\n\n

Kerry Rome kr@magventure.com or Lauren Schultheiss ls@magventure.com, MagVenture, Inc., +1.888.624.7764<\/p>\n<\/div><\/div><\/section>\n\n\n\n

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