BrainsWay Obtains FDA Approval for Deep TMS™ as Additional Treatment for Major Depressive Disorder in Teens Aged 15 to 21
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 13 2025
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Source: Newsfilter
FDA Approval: BrainsWay Ltd. announced that the FDA has expanded the label for its Deep TMS™ system to include treatment for adolescents aged 15 to 21 with major depressive disorder (MDD), addressing a critical gap in mental health care for this age group.
Clinical Evidence: The FDA's clearance was supported by a substantial dataset from 1,120 adolescents treated across 35 centers, showing significant improvements in depressive and anxiety symptoms after 36 treatment sessions.
Market Impact: This approval allows BrainsWay to treat both adults and adolescents with the same Deep TMS™ system, potentially reaching a significant number of the estimated 5 million adolescents in the U.S. who have experienced a major depressive episode.
Company Commitment: BrainsWay is dedicated to advancing noninvasive neurostimulation treatments and is actively conducting clinical trials for various psychiatric and neurological disorders, reinforcing its position as a leader in evidence-based mental health therapies.
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Analyst Views on BWAY
Wall Street analysts forecast BWAY stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for BWAY is 22.00 USD with a low forecast of 19.00 USD and a high forecast of 24.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 24.710
Low
19.00
Averages
22.00
High
24.00
Current: 24.710
Low
19.00
Averages
22.00
High
24.00
About BWAY
Brainsway Ltd is an Israel-based company engaged in the development and marketing of medical devices for the treatment of various neurological and psychopathological disorders. The Company primarily offers Transcranial Magnetic Stimulation (TMS) system, a medical device that enables direct non-invasive activation of deep brain structures. Its TMS system uses magnetic pulses to stimulate neurons and consequently modulates the physiological activity of the brain. TMS system is used in various clinical applications including: major depressive disorders, obsessive-compulsive disorder, smoking addiction and others various psychiatric, neurological, and addiction disorders.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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BrainsWay Secures Expanded Coverage for Depression Treatment from Highmark
- Policy Expansion: Highmark Blue Cross Blue Shield has released a draft policy expanding coverage to include adolescent and adult patients with major depressive disorder, expected to take effect in February 2026, marking a significant advancement for BrainsWay in depression treatment.
- Accelerated Treatment Protocol: The new policy includes BrainsWay's accelerated SWIFT™ protocol, which consists of five treatment sessions per day for six days, significantly reducing patient clinic visits and enhancing treatment accessibility and flexibility.
- Clinical Efficacy: BrainsWay's accelerated Deep TMS protocol received FDA clearance in September 2025, with clinical trials demonstrating an 87.8% response rate and a 78.0% remission rate, indicating comparable efficacy to standard Deep TMS and strengthening its market competitiveness.
- Market Outlook: With the implementation of this policy, BrainsWay is poised to attract more insurers to adopt its treatment protocols, further promoting the acceptance and accessibility of Deep TMS technology, thereby enhancing the company's leadership position in the mental health sector.
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