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BrainsWay Gains FDA Approval for Adolescent Depression Treatment

Story Highlights
  • BrainsWay received FDA clearance for Deep TMS as adjunct therapy for adolescents with MDD.
  • This approval positions BrainsWay as a leader in noninvasive depression treatment across a broad age range.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
BrainsWay Gains FDA Approval for Adolescent Depression Treatment

TipRanks Black Friday Sale

An announcement from Brainsway ( (BWAY) ) is now available.

On November 13, 2025, BrainsWay announced that it has received FDA clearance for its Deep TMS system to be used as an adjunct therapy for adolescents aged 15 to 21 suffering from major depressive disorder (MDD). This clearance allows BrainsWay to expand its market reach, making it the first and only TMS device approved for treating depression across a wide age range, from 15 to 86 years. The decision was based on a substantial dataset demonstrating the efficacy and safety of Deep TMS in reducing depressive symptoms and anxiety in adolescents. This milestone enhances BrainsWay’s position as a leader in noninvasive depression treatment, addressing a significant gap in effective therapies for adolescents with MDD.

The most recent analyst rating on (BWAY) stock is a Buy with a $23.00 price target. To see the full list of analyst forecasts on Brainsway stock, see the BWAY Stock Forecast page.

Spark’s Take on BWAY Stock

According to Spark, TipRanks’ AI Analyst, BWAY is a Outperform.

Brainsway’s strong financial performance and positive earnings call are the most significant factors driving the score. The company’s robust balance sheet and improved cash flow generation enhance its financial stability. However, the high P/E ratio and absence of a dividend yield are concerns for valuation. Technical indicators suggest a positive trend, but potential oversold conditions warrant caution.

To see Spark’s full report on BWAY stock, click here.

More about Brainsway

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The company specializes in Deep Transcranial Magnetic Stimulation (Deep TMS) technology, which is used to treat conditions such as major depressive disorder, obsessive-compulsive disorder, and smoking addiction. Founded in 2003, BrainsWay operates in the United States and Israel and is committed to increasing global awareness and access to its Deep TMS treatments.

Average Trading Volume: 74,000

Technical Sentiment Signal: Buy

Current Market Cap: $310.6M

For detailed information about BWAY stock, go to TipRanks’ Stock Analysis page.

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