Treated as drugs, not devices? Perhaps this is because the device is easily removable? I hope this would accelerate the review process.
Pivotal phase II/III: if enrollment were to begin soon, it would put I-vation TA not too far behind Medidur (currently enrolling phase III), although I believe Medidur has FDA fast track status. I wonder whether Medidur is also treated as a drug by the FDA?
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