Neuronetics Launches Major Registry To Track NeuroStar TMS Outcomes
The registry will collect data from more than 6,000 depression patients treated with transcranial magnetic stimulation at more than 100 different treatment facilities in the US to better understand how the therapy benefits patients in the "real world."
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The Helsinki-based company had expected stroke rehabilitation to be the first FDA-cleared indication for its Navigated Brain Therapy system, but while more data is collected for that program, it is pursuing a 510(k) clearance for NBS to treat major depressive disorder and plans to build a US salesforce to market NBS for therapeutic indications.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions over the past month. This edition takes a closer look at Respicardia, which has cut short the post-approval study of its implantable sleep apnea device study.
Noninvasive electromagnetic neurostimulation devices designed to improve peoples’ memory or learning abilities currently show some promise, but also feature unknowns surrounding their mechanisms of actions and long term effects, said speakers at an FDA workshop on the devices.