PHILADELPHIA The Juvenile Diabetes Research Foundation (JDRF; New York) has perhaps been the principal driver of a plausible clinical trial reality for closed-loop diabetes devices at FDA, which was widely seen as exhibiting an irrational reluctance to sign off on studies up to last year. JDRF's assistant VP for treatment therapies, Aaron Kowalski, MD, said the state of affairs at FDA is much improved from times gone by, but he told Medical Device Daily that another hurdle looms, namely the Centers for Medicare & Medicaid Services, which he said "has been a bit of a challenge." Read More
