Neuronetics - FDA 510(k) Cleared Devices

Neuronetics, 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 6 FDA 510(k) clearances from 7 total submissions since its first clearance in 2008. All submissions focused on neurology devices. The company's regulatory activity concluded in 2023, making this a historical record of its FDA clearance history.

The company's primary product is the NeuroStar Advanced Therapy System, a TMS platform indicated for major depressive disorder and obsessive-compulsive disorder. Clinical evidence supports safety, efficacy, and durability through 12 months of follow-up. The system has been used in over 8 million treatments across more than 235,000 patients.

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