Sorry I misread you. You are correct we do not know what the label will read. To my knowledge, that information has not been shared with us. Apparently it was necessary to reduce the number of applications in order to speed up approval. Its use will be restricted to what is on the label only. As Dean proves its effectiveness in the other areas the label will be expanded.
Just as with Botox, if physicians choose to use it for other applications they will do so. Dean may not sell it for any of those applications but once a customer has the device they are likely to try using it “off label” for many other applications. If they use it for non-labeled (approved) applications, some of which you have suggested, they do run some risk from a standpoint of liability. However since it is not a medication which could cause harm to a patient, it would be difficult to sue the physician for attempting to use every diagnostic tool in his arsenal. I am no lawyer, but I think my logic is correct.
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