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Neurotechnology / Treatment of bipolar disorder / Electrotherapy / Neurophysiology / Mood disorders / Transcranial magnetic stimulation / Neuronetics / Management of depression / Electroconvulsive therapy / Medicine / Psychiatry / Health


Medical PolicySection 2.0 Medicine Subsection
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City

Atlanta / /

Company

Brainsway Ltd. / Agency for Healthcare Research / /

Country

Germany / United States / Canada / Israel / /

Event

FDA Phase / Person Communication and Meetings / /

Facility

Blue Shield Technology Evaluation Center / /

IndustryTerm

implanted metal items / Treatment of Depression / treatment of all other psychiatric/neurologic disorders / treatment for depression / implanted magnetic-sensitive medical device / stimulation site / therapy for depression / treatment for a variety of other disorders / pretreatment magnetic resonance imaging / treatment of major depressive disorder / metal aneurysm clips / treatment protocols / motor stimulation site / resuscitation equipment / /

MedicalCondition

metal aneurysm / photophobia / major depressive disorder / headaches / dementia / fibromyalgia / seizures / severe major depressive disorder / psychiatric/neurologic disorders / cluster headache / panic disorder / convulsion / secondary tumors / nausea / schizoaffective disorder / cerebrovascular disease / postpartum depression / severe head trauma / phonophobia / obsessivecompulsive disorder / mild/moderate dementia / illness / future seizure / migraine headache / spinal cord injury / chronic migraine headache / Tourette syndrome / Schizophrenia / Parkinson disease / dysphagia / posttraumatic stress disorder / severe dementia / stroke / migraine / Seizure disorder / chronic psychotic symptoms / seizure / pain / psychiatric/neurologic brain disorders / epilepsy / Alzheimer disease / probable Alzheimer disease / Depression / treatment-resistant depression / tinnitus / disorders / Bipolar disorder / Obsessive-compulsive disorder / /

MedicalTreatment

deep brain stimulation / pharmacotherapies / antidepressant therapy / electroconvulsive therapy / sham treatment / treatment protocols / cochlear implant / basic cardiac life support / psychotherapy / resuscitation / cognitive behavioral therapy / pharmacotherapy / /

Organization

Food and Drug Administration / Blue Cross and Blue Shield Technology Evaluation Center / FDA / Agency for Healthcare Research and Quality / be performed using an FDA-cleared device / /

Position

psychiatrist / Medical Policy The physician / /

Product

Cerena™ TMS / TMS / /

Technology

CBT / magnetic resonance imaging / treatment protocols / /

URL

www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4273b1_00-index.htm / /

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