Neuronetics, Inc. - FDA 510(k) Cleared Devices

Neuronetics, Inc. develops non-invasive neurology devices for treating psychiatric and neurological disorders. The company specializes in transcranial magnetic stimulation (TMS) therapy systems, with a manufacturing facility in Malvern, US.

Neuronetics has received 8 FDA 510(k) clearances from 8 total submissions since its first clearance in 2016. All submissions focus on neurology devices. The company remains actively engaged in regulatory submissions, with its latest clearance in 2024.

The company's primary product platform is NeuroStar Advanced Therapy System, indicated for major depressive disorder, obsessive-compulsive disorder, and comorbid anxiety in adult and adolescent patients. NeuroStar represents the market-leading TMS technology, supported by extensive clinical evidence and real-world treatment data across thousands of patients.

Explore the complete list of cleared device names, product codes, and clearance dates in the regulatory database.