Soterix Medical Inc. (SMI), the global leader in non-invasive stimulation and synergistic technologies, announced today it has received a 510(k) clearance from U.S. Food & Drug Administration (FDA) for the Neural Navigator system manufactured by Brain Science Tools, Netherlands. The system is intended for accurate positioning of the treatment coil during repetitive Transcranial Magnetic Stimulation (rTMS) device for treatment of Major Depressive Disorder (MDD). Additionally, in combination with Electromyography (EMG) and single pulse Transcranial Magnetic Stimulation (TMS), the Neural Navigator can be used to localize cortical motor areas of the brain. This feature allows the use of the system for diagnostic purposes such as motor mapping to investigate functional reorganization after Stroke. This clearance allows formal marketing in the US of the only Neuronavigation system for rTMS / TMS and motor mapping that is not affected by line-of-sight occlusion.
“This FDA authorization represents a significant milestone for our organization as we can now offer the Neural Navigator system to rapidly increasing rTMS providers in the U.S.,” said Ms. Claudia Giselle, VP Regulatory Affairs of Soterix Medical. “The Neural Navigator has been designed to provide universal TMS compatibility, so this clearance sets the tone for additional formal approvals from the FDA.” Mr. Kamran Nazim, Chief Product Manager of Soterix Medical commented that, “The FDA clearance of this system was based on clinical evidence showing tracking and navigation system accuracy better than the predicate device”. “Additional benefits include highly intuitive software workflow, light weight, and the smallest footprint in its class that allows fitting into tight spaces.”
Psychiatrists and Neurologists in the United States interested in incorporating the Neural Navigator system are eligible for the Soterix Medical's Partnership program which includes support on the entire patient set-up pipeline, hands-on training and staff certification, MR image processing / data quality inspection, and connection to our network of physicians. Interested parties should contact Soterix Medical (at firstname.lastname@example.org) for additional information.
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