U.S. FDA Approves IDE for Bionic Pancreas
Egret Technologies congratulates its client Boston University, a leader in diabetes care research, on the FDA approval of their IDE for outpatient clinical studies using the latest bionic pancreas. This mobile-device platform, with closed loop algorithms running on the iPhone, integrating the Dexcom G4 Platinum continuous glucose monitoring (CGM) system with Tandem Diabetes t:slim infusion pumps, was developed in a multi-body partnership with Egret Technologies.
Ed Damiano, Associate Professor of Biomedical Engineering, Boston University said, “We'll be using this system in our first out-patient study (the Beacon Hill Study) starting next month. This is surely the most ambitious trial of a bionic pancreas system that has ever before been conducted. With these regulatory milestones behind us, we can now take our program to the next level. We're very excited to the get these studies underway." Learn More