No.
IDE is vastly different from FDA fast track designation.
IDE is a pre-requisite for any device used in a human trial that has not been FDA approved. New machine? Need IDE. Using a thermometer? Thermometer already has FDA approval.
FDA fast track designation is given to....I'll let you look that up.
You may need to research this company a little as they are developing new cancer detection technology.
Ann: Ceasing to be a substantial holder, page-64
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