Vagus Nerve Stimulation Erases PTSD

Re:Vagus Nerve Stimulation Erases PTSD by ajb on Wednesday May 07, 2025 @05:19PM (#43920673)

I'm skeptical of these devices that say they are safe based on CE or FCC testing. (zenbud says it has been CE tested). That's consumer product testing, not health-device testing; I would like to see some evidence that long-term use of a nerve stimulation device causes no long term damage. I don't believe that CE or FCC tests show that. It's disingenuous to have a press release saying "Yay! We passed CE testing!" as if that was like FDA approval.

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Re:Vagus Nerve Stimulation Erases PTSD by deno on Wednesday May 07, 2025 @05:59PM (#43920980)

FWIW the EU also has EUDAMED registry for producers, distributors and importers of medical devices and there are additional regulations beyond CE under the MDR directive.

I don't see "ZenBud" or "NeurGear" in the EUDAMED database.

An ultrasonic device delivering energy to human tissue would be a class 2a or 2b active medical device under MDR.

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