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.
NBT FDA (K171902): Nexstim's noninvasive NBT® System is cleared by the Food and Drug Administration. Nexstim Navigated Brain Therapy (NBT) System 2 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.
CE mark: Nexstim Navigated Brain Therapy System for depression is intended to be used for treatment of major depressive disorder (MDD) by targeting and delivering noninvasive repetitive TMS stimulation to the patient's dorsolateral prefrontal cortex.
The Nexstim NBT System is not cleared by the FDA for commercial use of the treatment of chronic pain in the United States, for investigational use only.
CE mark: Nexstim MRI-Guided and E-Field Navigated Brain Therapy System (Nexstim NBT® System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. Nexstim NBT System is indicated for MRI-guided and electric field (or E-field) navigated, noninvasive, repetitive TMS stimulation (rTMS) of the motor cortex as therapy to alleviate chronic unilateral neuropathic pain in adult patients.
Nexstim NBT® System is intended to be used by trained clinical professionals..