Nexstim NBS 5 NBR Module


 
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Indications for use:

NBS (FDA K112881): The Nexstim Navigated Brain Stimulation (NBS) System 5 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The Nexstim NBS System 5 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning.

The Nexstim NBS System 5 is not intended to be used during a surgical procedure. The Nexstim NBS System 5 is intended to be used by trained clinical professionals.

Nexstim NexSpeech®, when used together with the NBS System 5, is indicated for non-invasive localization of cortical areas that do not contain essential speech function. NexSpeech® provides information that may be used in pre-surgical planning in patients undergoing brain surgery. Intra-operatively, the localization information provided by NexSpeech® is intended to be verified by direct cortical stimulation.

The Nexstim NBS System 5 with NexSpeech® is not intended to be used during a surgical procedure. The Nexstim NBS System 5 with NexSpeech® is intended to be used by trained clinical professionals.

NBS 6 FDA (K171902): Nexstim's noninvasive NBS 6 is cleared by the Food and Drug Administration. NBS 6 is indicated 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.

Nexstim NBS 6 is intended to be used by trained clinical professionals.

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