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It is an intervention applied to living tissue, claiming to have medical benefits. It's a principle of medicine that anything present in quantities/intensities
by arkades 11y ago
It is an intervention applied to living tissue, claiming to have medical benefits. It's a principle of medicine that anything present in quantities/intensities sufficient enough to produce a beneficial response, is sufficient to produce a negative response (aka, side effects). Those need to be assessed and quantified.
If we changed the word "ultrasound" to read "laser", I suspect it would make the need for scrutiny more intuitive. "Ultrasound" has this connotation of being harmless.
- JoeAltmaier 11y agoSo is massage, or orange juice. That definition way too broad. I suppose the FDA has lots of criterion for what they manage. This is neither food nor drug.
- arkades 11y agoNo, it's a medical device, which falls squarely under their remit.
- nate_meurer 11y agoThis device alters your brain tissue. Damn straight it's going to be regulated. Massage isn't even in the same ballpark. Neither is OJ, which is regulated, just not by the FDA.
- JoeAltmaier 11y agoActually your brain alters itself, growing toward a more normal function. The treatment restores the ability to grow.