Neuronetics lands FDA clearance for TMS therapy accessory – Medical Device Network

Neuronetics has received US Food and Drug Administration (FDA) clearance for its NeuroSite Coil placement accessory, a tool that helps users with accurate coil placement.

US-based Neuronetics was the first company to receive FDA approval for its transcranial magnetic stimulation (TMS) devices called NeuroStar for treatment-resistant depression. The devices use a coil to deliver magnetic pulses that stimulate nerve cells in the brain in regions responsible for mood regulation.

The add-on will help with coil positioning and placement and reduce patient setup time, with Neuronetics stating the device is compatible with both legacy and new NeuroStar systems.

It will become available to NeuroStar providers in Q1 2024.

NeuroStar, which is also CE-marked, is a non-drug, non-invasive therapy for patients with major depressive disorder. It provides a valuable option for patients with the condition who do not respond to antidepressant medications. Neuronetics states its technology has been used to deliver more than 5.9 million treatments in 145,000 patients.

Up to 30% of patients diagnosed with major depressive disorder (MDD) have treatment-resistant depression.

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Neuronetics reported full-year 2022 revenue of $65.2m, up 18% from the previous year. The company expects a worldwide revenue of $66m-$72m.

In December 2021, the FDA cleared Neuronetics MT Cap technology to help map and determine motor thresholds the amount of energy required for treatment. In June 2023, the cap was cleared for use in patients with obsessive-compulsive disorder (OCD).

The company is also lining up the use of its technology in bipolar depression, after NeuroStar gained breakthrough device designation for the treatment of the condition in May 2020.

The TMS market is gaining traction, following mounting evidence of its efficacy. BrainsWays Deep TMS is also cleared for MDD, OCD and smoking cessation. Magnus Medical received FDA clearance for its SAINT neuromodulation system for the treatment of severe depression in September 2022.

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Neuronetics lands FDA clearance for TMS therapy accessory - Medical Device Network