The approval has been granted for the system to treat MDD in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current sequence.
TMS is a non-invasive technique that was developed to stimulate neural tissue in the part of the brain implicated in patients suffering with MDD.
MagVenture sales vice president Kerry Rome said: "MagVenture is very excited to begin offering the MagVita TMS Therapy system in the US. 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."
The MagVita system, along with other MagPro devices, are manufactured by the firm’s sister company Tonica in Denmark.
MagVenture develops non-invasive magnetic stimulation systems for depression treatment, as well as conducts research in the neurophysiology, neurology, cognitive neuroscience, rehabilitation, and psychiatry.
Image: MagVita TMS Therapy system has obtained FDA approval to treat major depressive disorder. Photo: courtesy of PRNewswire/ MagVenture Inc.