Regulators granted clearance for Flow Neuroscience’s wearable transcranial direct current stimulation (tDCS) headset as the first FDA‑cleared device intended for at‑home treatment of major depressive disorder. The decision followed a 2024 Phase II trial showing modest but statistically significant symptomatic relief versus controls; the FDA identified headaches and skin irritation as principal risks but judged benefit to outweigh probable harm. Flow will market the device by prescription; the company is in talks with payers over coverage. The approval establishes a precedent for tech‑based psychiatric therapeutics and likely accelerates investment and regulatory interest in non‑pharmacologic home interventions.