Story perspectives

BrainsWay Gains FDA Approval, Boosts Shares 11.9%

9/18/2025

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Summary

Story summary

BrainsWay Ltd. gained FDA clearance for an accelerated treatment protocol using its Deep Transcranial Magnetic Stimulation (TMS) system for major depressive disorder (MDD).
The protocol enables five sessions daily over six days, significantly shortening treatment duration.
Clinical trials indicated similar outcomes to standard treatment in depression score reductions and remission rates.
Following the announcement, BWAY shares increased by 11.9%, with a 79.2% year-to-date rise.
The company is improving provider training and seeking reimbursement updates to facilitate adoption.

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Story summary

BrainsWay Ltd. gained FDA clearance for an accelerated treatment protocol using its Deep Transcranial Magnetic Stimulation (TMS) system for major depressive disorder (MDD).
The protocol enables five sessions daily over six days, significantly shortening treatment duration.
Clinical trials indicated similar outcomes to standard treatment in depression score reductions and remission rates.
Following the announcement, BWAY shares increased by 11.9%, with a 79.2% year-to-date rise.
The company is improving provider training and seeking reimbursement updates to facilitate adoption.