FDA OKs Insulet’s Omnipod DASH System as an Alternate Controller Enabled Infusion Pump

Insulet Corporation, the developer of tubeless insulin pump technology with its Omnipod Insulin Management System, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for an Alternate Controller Enabled Infusion Pump (ACE Pump). This allows Insulet to market its Omnipod DASH Insulin Management System (Omnipod DASH System) as an integrated insulin pump (Omnipod DASH ACE Pump), allowing it to be a part of an interoperable automated insulin delivery (AID) system, such as the Company’s Omnipod Horizon Automated Insulin Delivery System¹.
 
“The diabetes industry is a dynamic and evolving landscape with technological and regulatory advancements enabling more interoperability and more patient choice in treatments and disease management,” said Shacey Petrovic, president and CEO. “Omnipod DASH was designed with interoperability in mind, and we’re thrilled to provide people with diabetes the choice and flexibility to manage their diabetes on their own terms. We commend the FDA’s interoperability efforts and look forward to working with the Agency as we continue to deliver our robust innovation pipeline.”
 
Insulet’s Omnipod DASH System was designed to serve as the foundation for the Company’s future innovation. Designed with user discretion and convenience in mind, the Omnipod DASH System is a continuous insulin delivery system consisting of two simple components: a tubeless, waterproof, Bluetooth wireless technology Pod (pump) that holds up to 200 units of U-100 insulin and a modern, color touch-screen Personal Diabetes Manager (PDM) that controls the Pod. The Omnipod DASH System has a suite of optional mobile apps for users, caregivers and HCPs to help simplify diabetes management. The Omnipod DASH System, which received FDA clearance in June 2018, is the only DTSec and ISO 27001 certified insulin pump for cyber and information security and safety.
 
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¹ CAUTION: Omnipod Horizon is an investigational device. Limited by United States Law to Investigational Use.