Core Insights - BrainsWay Ltd. (BWAY) has received FDA clearance for an accelerated treatment protocol using its Deep Transcranial Magnetic Stimulation (TMS) system for major depressive disorder, enhancing patient access and provider flexibility [1][4] - The new protocol requires fewer visits while showing comparable outcomes to the standard approach, which may facilitate stronger adoption in the mental health market [2][11] - Following the announcement, BWAY's shares increased by 11.9%, with a year-to-date gain of 79.2%, significantly outperforming the industry and S&P 500 [3] Company Developments - The accelerated Deep TMS protocol reduces treatment time to six days with five sessions per day, compared to the traditional four-week regimen, making it more convenient for patients [9] - Clinical trials demonstrated that the accelerated protocol achieved similar depression score reductions and remission rates as the standard method, with no severe adverse events reported [10][11] - BWAY is actively preparing provider training and reimbursement updates to support the wider adoption of the new treatment protocol [2][11] Market Position and Growth Potential - The FDA clearance positions BWAY to capture a larger share of the mental health market by offering a faster treatment option, potentially driving revenue growth and enhancing competitive differentiation [4][11] - BWAY has a market capitalization of $285.3 million and projects an earnings growth of 94.4% for the current year [5] - The global neuromodulation devices market is projected to grow from $5.80 billion in 2024 to $10.39 billion by 2030, with a CAGR of 8.51%, indicating favorable industry prospects for BWAY [12]