The FDA clearance indicates that the pump is capable of communicating securely with compatible, digitally connected devices
US-based medical device company Insulet has secured the US Food and Drug Administration (FDA) approval for its Omnipod DASH Insulin Management System as an Alternate Controller Enabled Infusion Pump (ACE Pump).
According to the FDA, ACE pumps are devices designed for infusing drugs into a patient, and securely communicate with compatible external devices, including automated drug dosing systems, allowing drug delivery commands to be received, executed, and confirmed.
ACE pumps can be used alone as drug delivery devices and in combination with digitally connected medical devices.
Insulet president and Chief Executive Officer Shacey Petrovic said: “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.
“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.”
FDA approval allows marketing the Omnipod DASH System as as an integrated insulin pump
The FDA approval allows Insulet to market Omnipod DASH System as an integrated insulin pump and makes the device a part of an interoperable automated insulin delivery (AID) system.
The clearance indicates that the pump is capable of communicating securely with compatible, digitally connected devices, including automated insulin dosing software, and to receive, execute, and confirm commands from these devices.
Insulet said that its Omnipod DASH System has met the FDA-established special controls that outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps.
In addition, the system was designed as a continuous insulin delivery system comprising two simple components, a tubeless, waterproof, Bluetooth wireless technology Pod (pump) capable of holding up to 200 units of U-100 insulin and a modern Personal Diabetes Manager (PDM) with touch-screen to control the Pod.
The Omnipod DASH System can be used through a set of optional mobile apps for users, caregivers and HCPs to help simplify diabetes management.