NeuroSphere received FDA clearance for the first home-use transcranial magnetic stimulation device intended for maintenance treatment of depression in patients who have previously responded to in-clinic TMS. The device, branded NeuroSphere Home, requires enrollment through a credentialed clinic and includes remote session monitoring by a clinician.
Maintenance protocols typically involve one to two sessions per week. Until now, those sessions required clinic visits, which posed a substantial logistical burden for patients who had completed an initial six-week course and were trying to sustain remission.
The device uses a head-positioning frame to standardize coil placement, with each session uploading session quality data to the supervising clinic. Stimulation parameters are pre-programmed by the prescribing clinician and cannot be modified by the patient.
Insurance coverage is not yet established. NeuroSphere indicated it will pursue both Medicare and commercial coverage in 2025, and is launching a patient assistance program for the interim. Initial pricing was disclosed at $895 per month.
Source
Reporting based on coverage from FDA Newsroom. This article is editorial summary intended for general information; it is not medical advice.