Heres my original question. What's not true?
Hi Doctor Fishman,
Great site! Have you ever heard of the "DVIS" scanner by imaging 3? I would really appreciate your take on this. They claim to be able to create and update a 3D construct in real time with a "O"arm and some fancy processing. After three years of back and fourths and much controversy with FDA. The company's 510K was found NSE early this year. Management first described the NSE finding as purely an administrative issue with the application. It was later discovered, through the use of the Freedom of information act, that the Device had issues and the FDA wanted clinical testing done. The company was previously awarded an IDE but never conducted or published any clinical trials. Shareholder have been begging for imagery but have been denied any information for years because management has claimed they cannot showed it for fear of upsetting the FDA. Can you shed any light on this? The company and insiders have billed this product as a game changing technology. Thanks for any comments!
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