Non-invasive magnetic stimulation developer MagVenture said last month it won FDA 510(k) clearance for its MagVita transcranial magnetic stimulation therapy system.
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.
“I am very pleased to hear of the clearance by the FDA of the MagVenture device for the treatment of major depression. The MagVenture device is the latest TMS device to be cleared by the FDA and offers a treatment alternative for psychiatrists who are managing cases of treatment resistant depression. I have personally worked with the MagVenture MagPro device for 7 years now and find its ease of use and reliability very attractive,” Dr. John O’Reardon of Rowan University said in prepared remarks.
MagVenture is the 4th company since 2008 to be receive clearance for magnetic brain stimulation devices, according to the company.
“MagVenture Inc. is very excited to begin offering the MagVita TMS Therapy system in the U.S. It was the first TMS system to be CE cleared in the EU (in 2011). The increased competitiveness in the market place will, ideally, drive down the cost of therapy and make the treatment modality an option for large numbers of depressed patients who were previously not able to receive TMS therapy due to the high cost,” sales veep Kerry Rome said in a press release.