These articles only apply to devices that work and Dean Janes ,the penny stock CEO's device does not ! That is why he refuses to have his device tested and validated. He never did the IDE and still has not done beta testing. The FDA will not allow him to re-submit without first doing clinical trials and he can not to any kind of testing because the device he is trying to scam the FDA with just does not produce real time 3D images and is just a hoax!!!
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