Tuesday, September 24, 2019
Insulet Corporation, the global leader in 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 System.
The Omnipod DASH System has shown that it meets the FDA-established special controls that outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps. The cleared indication for the Omnipod DASH System states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, and to receive, execute, and confirm commands from these devices.
“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 Chief Executive Officer. “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.”
