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BrainsWay Highlights FDA Approval of Neurolief’s At-Home Proliv Rx Device for Treatment-Resistant Depression

Story Highlights
  • On January 12, 2026, BrainsWay announced FDA Premarket Approval of Neurolief’s Proliv Rx, a Class III neuromodulation system for treatment-resistant major depressive disorder, approved for home and clinic use.
  • BrainsWay says the approval validates its strategic investment and option to acquire Neurolief, strengthening its neuromodulation leadership and expanding its potential market into at-home mental health treatments.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
BrainsWay Highlights FDA Approval of Neurolief’s At-Home Proliv Rx Device for Treatment-Resistant Depression

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

On January 12, 2026, BrainsWay Ltd. reported that the U.S. Food and Drug Administration granted Premarket Approval for Neurolief’s Proliv Rx neuromodulation system, a Class III device indicated as an adjunctive treatment for adults with major depressive disorder who have not responded adequately to at least one prior antidepressant, for use both at home and in clinical settings. The approval, which makes Proliv Rx the first and only FDA-approved at-home neuromodulation device for treatment-refractory MDD, is presented by BrainsWay as an early validation of its strategic investment and option to acquire Neurolief, reinforcing its competitive position among transcranial magnetic stimulation manufacturers and potentially expanding its addressable market by extending brain-stimulation-based care into the home environment.

The most recent analyst rating on (BWAY) stock is a Buy with a $25.00 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.

The score is driven primarily by improved profitability, strong cash generation, and a low-leverage balance sheet, reinforced by raised guidance and strong Q3 operating momentum. These positives are tempered by a demanding P/E valuation and technically stretched momentum signals that raise near-term pullback risk.

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

More about Brainsway

BrainsWay Ltd. is a global medical technology company specializing in advanced noninvasive neurostimulation treatments for mental health disorders. Its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) platform is FDA-cleared for major depressive disorder (including anxious depression), obsessive-compulsive disorder, and smoking addiction, with additional clinical trials underway in other psychiatric, neurological, and addiction indications. Founded in 2003 and operating in the United States and Israel, BrainsWay targets both U.S. and international markets and positions itself as a science-driven leader in neuromodulation-based mental health care.

Average Trading Volume: 78,535

Technical Sentiment Signal: Buy

Current Market Cap: $462.6M

Find detailed analytics on BWAY stock on TipRanks’ Stock Analysis page.

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