Neuronetics
 | |
| Private | |
| Founded | 2003 |
| Headquarters | Malvern, PA, United States |
Key people |
Christopher Thatcher, President & CEO Mark Bausinger, Chief Financial Officer Mark Demitrack MD, Chief Medical Officer Judy Ways, Ph.D., VP, Regulatory Affairs & Quality Assurance Stephen MacKinnon , VP, Sales = NeuroStar Transcranial magnetic stimulation Therapy System |
Number of employees | Approximately 120 |
| Website | www.NeuroStar.com |
Neuronetics is a privately held company developing non-invasive treatments for depression and other chronic psychiatric and neurological disorders based upon neuromodulation technology.
On September 1, 2010, the World Economic Forum announced the company as a Technology Pioneer for 2011.[1]
Products
Neuronetics' first product, the NeuroStar TMS Therapy System is designed to non-invasively stimulate the brain using highly focused MRI-strength magnetic pulses, or transcranial magnetic stimulation (TMS). NeuroStar delivers therapy that is highly targeted, involving a brain region that is thought to be involved in depression. NeuroStar TMS Therapy is prescribed by a psychiatrist and is delivered in an outpatient setting. The patient sits in the chair and undergoes 40-minute sessions over the course of four to six weeks.[2]
FDA Actions
In January 2007 an advisory panel of the United States Food and Drug Administration (FDA) stated that a TMS device had a good safety profile but had failed to demonstrate that it was effective for the treatment of depression in patients with a range of 1-4 prior antidepressant treatment failures.[3]
In October 2008, based on the safety and efficacy of rTMS in patients with major depression who failed to benefit from 1 prior antidepressant medication, the FDA cleared the TMS device for marketing. The rTMS device was cleared by the FDA De Novo process whereby the device was reclassified to Class II based on safety and efficacy in the indicated population and therefore not subject to premarket approval.[4]
References
- ↑ Thirty-One Visionary Companies Selected as Technology Pioneers 2011
- ↑ Smith, Aaron (2007-01-26). "FDA to consider depression-fighting machine: NeuroStar machine could compete with antidepressant drug industry, if it wins FDA approval". CNNMoney.com. Cable News Network. A Time Warner Company. Retrieved 2010-09-23. External link in
|work=(help) - ↑ Scudiero, JL (2007-01-26). "Brief Summary From the Neurological Devices Panel Meeting - January 26, 2007". FDA. Retrieved 2010-07-14.
- ↑ Janicak, PG; O'Reardon, JP; Sampson, SM; Husain, MM; Lisanby, SH; Rado, JT; Heart, KL; Demitrack, MA (2008). "Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment". The Journal of Clinical Psychiatry. 69 (2): 222–32. doi:10.4088/jcp.v69n0208. PMID 18232722.