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BrainsWay Secures FDA Approval for Faster Depression Treatment

9/18/2025

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Story summary
  • BrainsWay Ltd. gained FDA clearance for a six-day accelerated treatment protocol using its Deep TMS system for major depressive disorder (MDD).
  • This new approach requires fewer visits than the standard four-week treatment.
  • Clinical trials demonstrated similar outcomes in depression score reductions and remission rates between both protocols.
  • No severe adverse events were reported, confirming the treatment's safety.
  • Following the announcement, BrainsWay's stock increased by 11.9%.