Clinical Application | European Union (CE mark) | United States (FDA) |
Pre‑procedural Mapping | CE‑marked | FDA cleared |
Post‑operative Motor Rehabilitation | CE‑marked | Investigational use only |
Major Depressive Disorder (Adults) | CE‑marked | FDA cleared |
Major Depressive Disorder (Adolescents) | Not CE‑marked | FDA cleared |
Obsessive‑Compulsive Disorder | Not CE‑marked | FDA cleared |
Chronic Neuropathic Pain | CE‑marked | Investigational use only |
For information on other regional clearances, please contact us at info@nexstim.com.
Indications for use & Intended purpose texts, pertaining to our regional approvals:
Pre-procedural mapping (CE mark, FDA clearance, for information on other regional clearances contact Nexstim):
Intended purpose: NBS 6 is intended to be used for localization and assessment of the motor cortex and motor tract integrity for pre-procedural planning purposes. NBS 6 is intended to be used for localization and assessment of cortical areas of speech function for pre-procedural planning purposes.
Indications for use: NBS 6 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. NBS 6 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. NBS 6 is indicated for non-invasive localizations of cortical areas that do not contain essential speech function. NBS 6 provides information that may be used in pre-surgical planning in patients undergoing brain surgery. Intraoperatively, the localization information provided by NBS 6 is intended to be verified by direct cortical stimulation. NBS 6 is not intended to be used during a surgical procedure. NBS 6 is intended to be used by trained clinical professionals.
Post-operative Rehabilitation (CE mark, for information on other regional clearances contact Nexstim):
Intended purpose: NBS 6 is intended to be used for the treatment of surgically induced new or worsening post-operative motor deficits of the upper limb as an adjunct therapy for motor rehabilitation in adult patients having undergone brain tumor surgery. NBS 6 is intended to be used by trained clinical professionals.
Nexstim NBS 6 is not cleared by the FDA for commercial use of post-operative rehabilitation in the United States, for investigational use only.
Chronic Neuropathic Pain (CE mark, for information on other regional clearances contact Nexstim):
Intended purpose: In adult patients suffering from chronic unilateral neuropathic pain, NBS 6 is intended to provide electric field navigated non-invasive repetitive TMS stimulation as therapy to alleviate pain. NBS 6 is intended to be used by trained clinical professionals.
Indications for use: NBS 6 is indicated for MRI-guided and electric field (or E-field) navigated, non-invasive repetitive TMS stimulation (rTMS) of the motor cortex as therapy to alleviate chronic unilateral neuropathic pain in adult patients. Nexstim NBS 6 is intended to be used by trained clinical professionals.
Nexstim NBS 6 is not cleared by the FDA for commercial use of the treatment of chronic pain in the United States, for investigational use only.
Major Depressive Disorder (CE mark, FDA clearance, for information on other regional clearances contact Nexstim):
Intended purpose: NBS 6 is intended to be used for treatment of major depressive disorder (MDD) by targeting and delivering non-invasive repetitive TMS stimulation to the patient's dorsolateral prefrontal cortex.
Indications for use: 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. NBS 6 is intended to be use by trained clinical professionals.
Adolescent Major Depressive Disorder (FDA clearance, for information on other regional clearances contact Nexstim):
Indications for use: NBS 6 is indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).
Obsessive-Compulsive Disorder (FDA clearance, for information on other regional clearances contact Nexstim):
Indications for use: NBS 6 is indicated as an adjunct for the treatment of adult patients suffering from obsessive-compulsive disorder (OCD).
