Trials for external, easily removable devices are just not as big a deal to the FDA. Not as rigorous.
Additionally, the thing that people forget is that the device is said not to affect normal tissue at all. And it does not “kill” tumor tissue either. What it is supposed to do is slow the growth of tumor tissue. It has a completely different purpose than many if not most of the available treatments. But I do not think they really have to demonstrate too rigorously that what they said happens, actually happens.
It’s the nature of this sort of optionally wearable device. And how frequently patients wore it, how well they could tolerate it, leads likely to very unreliable data for projecting out that kind of “efficacy”. But the regs are such that, for these kinds of non-drug, external devices that may or may not do very much, the purpose of the trial is not likely to allow marketing of the device, but to be able to make “claims” and charge a huge premium.
On that last point, basically I would say the FDA failed in this instance. Being able to make those kinds of claims based upon the level of rigor involved, or lack thereof, and then charge obscene amounts, seems more like a return to the days of snake oil than I’d like to think we’d do in this modern age.
But what can you do. They found an option, a treatment idea that threaded the needle of regulatory control and got them a massively profitable opportunity.
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