In January 2013, the FDA approved Deep TMS therapy developed by Brainsway for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder, who failed to achieve satisfactory improvement from any number of previous antidepressant medication treatment in the current episode. Deep TMS has been used in several other countries and is under investigation for several other conditions.
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The following TMS systems have been cleared by the FDA to treat Major Depression.
CloudTMS is manufactured by Neurosoft, Ltd. a global leader in the development of TMS devices since 1996 with thousands of TMS machines operated in psychiatric and neurological clinics in the US and around the world. The CloudTMS system has received FDA clearance for the 37.5 and 19 minutes treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. CloudTMS has an installed customer base of over 1500 devices worldwide and received regulatory clearances in more than 25 countries.
Magstim are the pioneers of Transcranial Magnetic Stimulation technology, bringing over 25 years of experience into clinical practice. In May 2015, Magstim received FDA 510 (k) clearance to market its Rapid2 Therapy System for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Magvita TMS Therapy
On July 31st, 2015, MagVenture received FDA 510(k) clearance to market the MagVita TMS Therapy® system for Major Depressive Disorder. MagVita TMS Therapy is indicated for adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. In 2011, MagVenture’s MagVita TMS therapy System was the first to receive a European clearance.
Neurostar Advanced Therapy
In October 2008, the FDA approved TMS Therapy using the NeuroStar Advanced Therapy brain-stimulating device for patients suffering from Major Depressive Disorder who have failed to receive satisfactory improvement from antidepressant medication in the current episode. Neuronetics pioneered clinical TMS practice in the US with over 850 systems placed. They played a pivotal role in educating the public and clinicians on TMS and advocating for insurance coverage across the country. NeuroStar was the first to receive FDA clearance for a 19-minute treatment time and they provide the most comprehensive practice support and service program guaranteeing 99% customer uptime.