Non-invasive magnetic stimulation developer MagVenture said today it won FDA clearance for an entry-level version of its MagVita transcranial magnetic stimulation device designed for treating major depressive disorder.
The Atlanta-based company said that the newly cleared device is designed specifically for smaller psychiatric practices looking to begin to provide TMS services but are unsure of their patient flow.
“The new FDA cleared MagVita TMS therapy system is tailormade for healthcare professionals seeking an entry-level TMS system without having to compromise on quality and safety. The device, which is also CE marked in Europe, has proven to be a popular choice among clinicians in many countries across the world. Additionally, more and more insurance companies now cover TMS for depression, and this solution will enable even more clinics to get on board and start to offer TMS for the treatment of depression,” MagVenture sales VP Kerry Rome said in a prepared statement.
MagVenture originally won FDA 510(k) clearance for its MagVita TMS therapy system in August 2015.
The device, which uses magnetic fields and electric currents to excite and depolarize neurons in the brain and nervous system, is indicated for treating major depressive disorder in patients non-receptive to antidepressant medication, the company said.