MALVERN, PA — Neuronetics, Inc. (NASDAQ: STIM), a leading medical technology company specializing in innovative solutions for mental health, has announced that its NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy System has received expanded regulatory approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. This approval covers several proprietary technological advancements designed to enhance patient experience and streamline clinician workflow.
Among the approved features are the NeuroStar 3.7 platform, MT Cap, D-Tect™ MT Accessory, and the Dash treatment protocol. The latter reduces daily TMS treatment time by almost half, from 38 minutes to under 19 minutes. The MT Cap and D-Tect simplify the process of determining a patient’s motor threshold (MT), a critical step in establishing a treatment prescription. Meanwhile, the NeuroStar 3.7 platform enhances computing power by 60% and includes a touchscreen display with a biometric fingerprint reader.
“Depression is an increasing concern in Japan,” stated Keith J. Sullivan, President, and CEO of Neuronetics Inc. “Ever since NeuroStar was approved through Japan’s rigorous Shonin pathway in 2017, we have been dedicated to supporting clinicians and patients seeking alternatives to medication. We are eager to elevate patient care and treatment efficiencies with our advanced technology.”
Depression is a significant issue in Japan, affecting an estimated 2.4 million adults, and approximately 655,000 are undergoing treatment. Among these, around 475,000 patients have not achieved remission through antidepressant medications. NeuroStar TMS Therapy aims to address this gap through its exclusive distribution partnership with Teijin Pharma Limited.
NeuroStar’s recent approvals in South Korea, EU-MDR, and MDSAP certifications are testament to its global growth strategy. The company is committed to advancing mental health care worldwide by seeking clearance for new technological innovations and indications as supporting data becomes available.
NeuroStar’s advanced approval in Japan marks a significant milestone not only for the company but also for depression treatment in the country. This development could potentially transform the lives of thousands of patients, offering a fresh ray of hope in their battle against depression.
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