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Wednesday, April 19, 2023 12:09:21 AM
Now you understand why it doesn't have really any sales and why it isn't medically reimbursed?
It is a device that was brought to market with a 510k (Pre-market notification) which is not the same as a PMA (Pre-Marketing Authorization). The former relies on an exemption of the FDA requirements due the device being "substantially equivalent" to a predicate device already on the market before the FDA began regulating medical devices in 1976. That means that it lacks scientific rigor to make certain claims, rather it is simply deemed relatively safe. So it likely won't kill you but also not really certain it will do anything.
This is why I have been vigorously claiming that it has merely a bunch of very small studies that show some promise but really need much larger well controlled studies.
There are a ton of competitor products for acute pain and longer lasting local anesthetics, like the one used in the study are very effective, also combining NSAIDs and acetaminophen are effective as well.
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