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FDA clears second interoperable insulin pump

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The FDA cleared Insulet to market its tubeless Omnipod DASH Insulin Management System as an integrated insulin pump, allowing it to be part of an interoperable, automated insulin delivery system, according to an industry statement released Monday.

The Omnipod pump is the second device to be classified under a new de novo premarket review pathway, a regulatory pathway for novel, low- to moderate-risk devices of a new type, according to the FDA. The FDA cleared the device as an alternate controller enabled infusion pump, or ACE pump, allowing it to be a part of an interoperable automated insulin delivery system, such as Insulet’s Omnipod Horizon Automated Insulin Delivery System.

The cleared indication for the Omnipod 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, according to Insulet.

“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,” Shacey Petrovic, president and CEO of Insulet, said in the release. “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.”

In February, the FDA cleared the Tandem Diabetes Care t:Slim X2 insulin pump as an ACE insulin pump, becoming the first interoperable pump cleared for children and adults with diabetes by the FDA. In announcing the decision, then FDA Commissioner Scott Gottlieb, MD, said future ACE insulin pumps will be able to go through the more efficient 510(k) review process, potentially helping to advance the technology. – by Regina Schaffer

Disclosures: Petrovic is president and CEO of Insulet.