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The development and evaluation of neuromodulation devices, including DBS, VNS, TMS, and tDCS.
A review of the provided reporting finds no published clinical trials that specifically evaluate ’s or technologies; NeuroDyne is described as a startup advancing EEG hardware but the sources do not l...
The FDA offers two distinct non-510(k) routes for novel neuromodulation devices: De Novo, a classification pathway for first‑of‑a‑kind low‑ to moderate‑risk devices, and Premarket Approval (PMA), the ...
A review of the supplied reporting finds no clear, new large multi‑site randomized trials of rTMS for tinnitus that were explicitly planned or funded since 2023; the literature instead emphasizes a co...