As we begin the new year, an important development in depression treatment is underway. The FDA has just cleared the first at-home brain-stimulation device for major depressive disorder: the Flow Neuroscience FL-100 headset. It pairs with a mobile app so patients can use it at home while still being monitored by their clinician, typically in 30-minute sessions over several weeks. Similar versions have already been in use outside the U.S. since 2019, and U.S. availability is expected in the second quarter of 2026. This device is likely to make neuromodulation more accessible while also raising important questions about patient selection (it is not cleared for use for patients considered treatment-refractory, although that terminology remains somewhat vague), clinical oversight, and reimbursement.