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FDA grants 510k clearance to MagVita TMS
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The FDA recently granted 510k clearance to market MagVita TMS therapy, a repetitive transcranial magnetic stimulation system, for treatment of depression.
“The new FDA cleared MagVita TMS Therapy system is tailor-made for health care professionals seeking an entry-level TMS system without having to compromise on quality and safety,” Kerry Rome, BS, vice president of sales at MagVenture Inc, said in a press release.
The MagVita TMS therapy system was first cleared by the FDA in 2015 for treatment of major depressive disorder.
The newly cleared device is intended for use in smaller psychiatric practices, particularly those that want to provide TMS but are unsure of patient flow.
“The device, which is also CE marked in Europe, has proven to be a popular choice among clinicians in many countries across the world,” Rome said in the release. “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.”