Korean medtech company EOFlow said last week that it won breakthrough status from the FDA for its closed-loop automated insulin delivery system for people with Type 1 diabetes.
The EOPancreas system features a wearable patch, continuous glucose monitoring systems and a closed-loop blood glucose control algorithm.
“EOFlow was founded to democratize wearable drug delivery solutions by providing intelligent, connected solutions for patients managing chronic conditions at globally-competitive price points and we see the Breakthrough Device designation as an important validation of our business model,” founding CEO Jesse Kim said in prepared remarks.
“Recent published results such as those from the T1D Exchange registry emphasize the continuing challenge for achieving target levels of glucose control for patients with Type 1 diabetes. Even with the increasing use of CGM systems, greater improvements in clinically meaningful endpoints, such as hemoglobin A1c and time in range are needed. Closed loop systems, such as the EOPancreas System, can be attractive tools to improve glycemic control,” Dr. David Klonoff, professor of medicine at U.C. San Francisco, added.
Earlier this year, Medtronic (NYSE:MDT) won breakthrough status from the FDA for its investigational closed-loop insulin delivery system. The medtech titan was the first to win FDA approval for a hybrid closed-loop insulin delivery system. The FDA approved Medtronic’s MiniMed 670G system in September of 2016.