The medical device company Neuronetics, Inc. recently got clearance from the U.S. Food and Drug Administration (FDA) for another use for its NeuroStar Advanced Therapy for Mental Health treatment. Neuronetics’ transcranial magnetic stimulation (TMS) system now has the go-ahead to treat people with anxious depression, otherwise known as major depressive disorder (MDD). This FDA clearance comes on the heels of NeuroStar’s previous clearance for treating obsessive compulsive disorder (OCD), which it received earlier this year.
So what exactly is TMS? It’s a noninvasive non-drug treatment that uses magnetic pulses to stimulate the brain’s nerve cells to reignite dormant synapses. Not to be confused with shock therapy or electroconvulsive therapy (ECT), TMS works by placing an electromagnetic coil against the patient’s forehead to send targeted pulses to mood-regulating areas of the brain. Neuronetics explains it as “waking up the brain to function as it was meant to.” The outpatient treatment takes about 20 minutes per session in which the patient may feel a tingling, tapping, or warming sensation when the coil is applied.
This most recent FDA approval includes the use of real-world data from Neuronetics’ TrakStar platform, which uses data from NeuroStar patients who were treated at more than 1,000 centers. The results of each NeuroStar session are gathered by TrakStar, and the data that’s collected by this proprietary HIPAA-compliant reporting system can be shared with healthcare providers and is available for download to mobile devices.
The newly approved treatment meets a massive need. One of the most common mental disorders in the United States, MDD affects an estimated 17.5 million Americans according to the National Institutes of Health. Globally, the World Health Organization estimates that 5% of adults suffer from depression. Neuronetics CEO Keith J. Sullivan says, “Many people suffering from MDD also experience anxiety symptoms, and these patients with anxious depression are more likely to be severely depressed and to have more thoughts of suicide.”