Omnipod DASH™ System Receives ACE Infusion Pump Clearance from FDA

Omnipod with app.

– Shahd Husein

Insulet, the makers of the Omnipod DASH™ System, recently received federal clearance from the U.S. Food & Drug Administration (FDA) for an Alternate Controller Enabled Infusion Pump, or ACE pump. Business Wire notes that this clearance grants Insulet permission to sell their DASH™ system as an integrated insulin pump and to also join an “interoperable automated insulin delivery (AID) system,” like their Omnipod HORIZON™ Automated Insulin Delivery System.

According to the FDA, an ACE pump is a device that is used for the “infusion of drugs into a patient.” The agency outlines requirements to test certain criteria such as reliability, cybersecurity, clinical relevance, and accuracy of these devices. ACE pumps can also be used alone or with a digitally connected medical device to administer drugs.

The Omnipod DASH™ System delivers insulin continuously to individuals with diabetes, and consists of a tubeless Bluetooth-enabled Pod, as well as a Personal Diabetes Manager (PDM) that controls the Pod. The Omnipod DASH™ System also supports mobile apps such as Omnipod DISPLAY™ for individuals with diabetes as well as Omnipod VIEW™ for caregivers. With these features in mind, the announcement declares that Insulet’s system can “reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, and to receive, execute, and confirm commands from these devices,” states Healio.

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Beyond the clearance of their DASH™ system, Insulet looks forward to increased federal prioritization of interoperability, as it opens up the possibility for a variety of diabetes management discoveries, reports Yahoo Finance.

“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,” said Shacey Petrovic, President and CEO of Insulet. 
Earlier this year, the FDA also cleared Tandem Diabetes Care’s t:Slim X2 insulin pump as an ACE insulin pump.

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