The U.S. FDA granted Neuronetics Inc. clearance for use of its Neurostar advanced therapy as an adjunctive treatment of major depressive disorder in patients aged 15 to 21, making it the first transcranial magnetic stimulation treatment (TMS) cleared for this age group, the company said.
Neuronetics Inc. gained expanded approval in Japan for its transcranial magnetic stimulation (TMS) system to treat major depressive disorder called the Neurostar TMS, helping the Malvern, Pa.-based company increase its footprint in Asia.
Results from a new study suggest that treatment with Magnus Medical Inc.'s Saint neuromodulation system causes abnormal brain signals to become normal by reversing the direction brain signals flow in severely depressed individuals. The researchers also identified a new biomarker that could help doctors diagnose and treat major depressive disorder (MDD).
Magstim Inc. received U.S. FDA clearance for use of its Horizon 3.0 and E-z Cool Coil to treat adult patients diagnosed with both obsessive compulsive disorder (OCD) and major depressive disorder (MDD). The company’s non-invasive transcranial magnetic stimulation (TMS) therapy offers an option for patients who do not find adequate relief from the often life-disrupting symptoms of OCD with exposure therapy or medication.
The FDA has greenlighted Neuronetics Inc.’s Neurostar transcranial magnetic stimulation (TMS) system as an adjunct treatment for adults with obsessive-compulsive disorder (OCD). The noninvasive treatment, which uses repetitive, focused magnetic pulses to stimulate brain cells, is already cleared and marketed in the U.S., Japan and select other countries for major depressive disorder (MDD).
The FDA granted 510(k) clearance to Neuronetics Inc.’s MT Cap technology for the company’s transcranial magnetic stimulation system, Neurostar Advanced Therapy for Mental Health. The MT Cap speeds the process used to determine the dose and motor threshold for treatment with the Neurostar system for major depressive disorder (MDD). The company expects to begin a limited introduction of the product within weeks, with national rollout to follow in the first quarter of 2022.
Neuronetics Inc., of Malvern, Pa., has won U.S. FDA breakthrough device designation for its Neurostar transcranial magnetic stimulation (TMS) device for the treatment of patients with drug-resistant bipolar depression. The news comes as the company reported a strong fourth quarter for 2019, with revenue up 11% year-over-year to $17.4 million.
The routine application of medical device technology to neurological indications beyond pain remains challenging in all but the most severe patients. Micro-cap Neuronetics Inc. is aiming to change all that with its Neurostar transcranial magnetic stimulation (TMS) system that is noninvasive and used in the physician's office.
