Transcranial magnetic stimulation tech dev MagStim said yesterday that it won FDA 510(k) clearance for and launched its StimGuide TMS navigation system, touting it as the first device of its kind.
The Eden Prairie, Minn.-based company said that the device is intended for use with its Horizon Performance TMS therapy system. The newly launched device is designed to provide precise and consistent coil positioning during treatments for major depressive disorder.
“I am thrilled that this technology is now available. As the TMS research field continues to advance towards treating targets tailored for each patient, a tool like StimGuide provides a solution for simple, repeatable, and precise coil positioning,” Dr Mark George of the Medical University of South Carolina said in a press release.
The StimGuide aligns four parameters to guide clinicians to areas for treatment and to reduce potential variability, the company said.
“I am convinced that StimGuide will improve patient care because it ensures reliable placement over the intended treatment target providing confidence to experienced and new TMS treaters. StimGuide accurately measures the distance of the coil from the intended target as well as rotation and pitch ensuring every pulse train is delivered in the optimal coil position,” Magstim group CEO Lothar Krinke said in a prepared statement.
Magstim said that the StimGuide device is already in use across the U.S. as part of a clinical study that aims to measure the quality of TMS pulses delivered during treatment sessions.
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