MagPro stimulators and magnetic coils are approved as medical devices in Europe, the USA, Canada, China, Japan, South Korea, Australia, Russia, Brazil, and other markets worldwide.

EU: CE approved for treatment of Major Depressive Disorder

MagVenture TMS Therapy is CE approved for “Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from two prior antidepressant medications, at or above the minimal effective dose and duration in the current episode”.

EU: CE approved for diagnostic use

The MagPro is intended as an electro-physiological aid to assess diagnosis and to monitor diseases of the central and peripheral nervous system, based on the use of Motor Evoked Potential (MEP).

USA

United States federal law regulates the sale of Medical Devices. The US Food and Drug Administration (FDA) grants clearance to manufacturers to market devices for specific indications, after safety and efficacy have been demonstrated, by issuance of either a 510(k) or PMA clearance.

USA: FDA cleared for treatment of Major Depressive Disorder

MagPro^® stimulators R20, R30, R30 with MagOption, X100, and X100 with MagOption are all FDA 510(k) cleared for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode (k170114, k150641 and k171481).

USA: FDA cleared for adjunct treatment of Obsessive-Compulsive Disorder

MagPro stimulators R30, R30 with MagOption, X100 and X100 with MagOption are all FDA 510 (k) cleared as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD) (k193006)

USA: FDA cleared for stimulation of peripheral nerves for diagnostic purposes

MagPro^® stimulators R20, R30, R30 with MagOption, X100, and X100 with MagOption are all FDA 510(k) cleared for stimulation of peripheral nerves for diagnostic purposes (k160280, k061645, k091940).
The use of MagPro devices for other than FDA cleared intended uses is considered investigational. In accordance with US federal regulations, an IDE and/or IRB approval may be required for use of MagPro devices for uses distinct from the FDA cleared Indication(s) for Use. The sponsor is responsible for obtaining appropriate, required approvals. please consult FDA's website (www.fda.gov) for more information.

All investigational devices must be labeled in accordance with the labeling provisions of the IDE regulation (§ 812.5) and must bear a label with this statement:

"CAUTION 
Investigational Device. Limited by Federal (or United States) law to investigational use."

For further information please contact:
MagVenture, Inc.
2300 Lakeview Parkway, Suite 700
Alpharetta GA 30009
Phone: +1 888-MAGPRO-4 (+1 888 624 7764)
Fax: +1 678-809-1415
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
www.magventure.com