SAN DIEGO -- The FDA has issued the first part of a three-pronged strategy for bringing to market a closed-loop insulin delivery system, otherwise known as the artificial pancreas. In this InFocus report, staff writer Kristina Fiore sits down with Chip Zimliki, PhD, director of the FDA's critical pathway initiative for the artificial pancreas, to talk about this first step, which focuses on low glucose suspend -- a technology that enables automatic shutoff of insulin infusion to prevent hypoglycemia. The guidance will give clinicians involved in studies of these devices appropriate safety and efficacy endpoints, and Zimliki, who is in fact also a type 1 diabetic, previews the two other guidances yet to be issued.

Fuente: www.medpagetoday.com/MeetingCoverage/ADA/27291