FDA Clears BrainsWay Deep TMS for Adolescent Depression Therapy
BrainsWay Ltd. has received FDA clearance for its Deep TMS™ system to treat major depressive disorder in adolescents aged 15 to 21. This makes it the first TMS device approved for this age group. The decision was based on data from over 1,100 adolescents, showing significant improvements in depressive and anxiety symptoms. Clinicians can now use the same Deep TMS™ system for both adults and adolescents.
BrainsWay Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted a label expansion for its Deep Transcranial Magnetic Stimulation (Deep TMS™) system, allowing its use as an adjunct therapy for major depressive disorder (MDD) in adolescents aged 15 to 21. This clearance makes Deep TMS™ the first and only TMS device approved for treating depression in patients aged 15 to 86. The FDA’s decision was supported by real-world data from over 1,100 adolescents treated across 35 U.S. centers, demonstrating significant improvement in depressive and anxiety symptoms. This regulatory milestone enables clinicians to treat both adults and adolescents with the same Deep TMS™ system and protocols. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Brainsway Ltd. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001171843-25-007250), on November 13, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
