The Food and Drug Administration (FDA) has cleared Magstim’s Horizon 3.0 Transcranial Magnetic Stimulation (TMS) Therapy System as an adjunctive nonpharmacological therapy for major depressive disorder (MDD) in adolescent patients aged 15 to 21 years. Previously, the TMS system was only indicated for adults with MDD who had failed to achieve satisfactory improvement from prior antidepressant medications.
The Horizon 3.0 TMS Therapy System is a computerized, noninvasive medical device that directs electrical currents at different regions of the cerebral cortex. The device can only be utilized through a prescription under the supervision of a physician in both inpatient and outpatient settings.
The Horizon 3.0 TMS Therapy System has 3 different configurations, which include Horizon 3.0, Horizon 3.0 with StimGuide Pro, and Horizon 3.0 Inspire. All systems have the same indications for use, main components, operating principles, and technological features.
The FDA clearance now allows physicians and nurse practitioners to gain authorization from insurance providers to treat adolescent patients. Practices with Magstim Horizon systems may now begin treating adolescent patients after following standard patient care protocols.
“Through this FDA approval, thousands of adolescent patients with depression will be able to take advantage of our nonpharmacologic advanced technology,” said Ronnie Stolec-Campo, CEO, Magstim. “Magstim is now the only TMS system which can treat MDD, anxious depression, OCD, and adolescent depression with a single treatment coil.”
Participants interested in learning more about Magstim Horizon can visit Magstim.com or call 844-624-7846.
This article originally appeared on MPR
References:
- FDA clears Magstim Transcranial Magnetic Stimulation System for US adolescent patient treatment. News release. Magstim. March 19, 2025. https://www.globenewswire.com/news-release/2025/03/19/3045356/0/en/FDA-Clears-Magstim-Transcranial-Magnetic-Stimulation-System-for-U-S-Adolescent-Patient-Treatment.html.
- US Food and Drug Administration. Magstim Company LTD/ Re: K241518. Trade/Device Name: Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0). https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241518.pdf.