FDA approval shouldn't and thankfully doesn't
rely upon an audience of shareholders oooing and awing over a 2 dimensional fist opening and closing. Lay people are often fooled by medical imaging charlatains. Richard Secord and Jacob Greene are two that come to mind.
FDA sets a high bar so that when you go in for surgery, you can be assured that the blood vessel being cut by the surgeon's scalpel is not actually your spinal cord.
FDA serves patients, not shareholders.
If the device truly did work, why didn't Dean submit the image comparisons the FDA specifically asked for? They appear never to have been done even to this day.
Also, why the reluctance by Dean in disclosing the compensation given to the radiologists whose opinion was given in the original submission.
Those 2 items have nothing to do with FDA bureaucracy. They are common sense.
Would you have your son or daughter's spinal surgery guided by DVIS WITHOUT absolute proof it gives diagnostically useful information?
With proof--I'm 100% behind it. Without proof after all these years, I'm 100% certain this is a scam.
No one buys $500,000 imagers without multiple independent clinical studies backing the technology. That Dean keeps making excuses and meetings delaying the collection of data is all you should need to know.
Shareholders being shown a 2d fist opening and closing prove nothing.
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