Insulet (NSDQ:PODD) said today that it won FDA clearance to market its Omnipod Dash alternate controller-enabled (ACE) infusion pump as an integrated insulin pump.
The Acton, Mass.-based company received FDA 510(k) clearance for the Omnipod Dash in June 2018 and launched the device earlier this year. The latest indication states that the pump can reliably and securely communicate with compatible devices.
The Omnipod system is a continuous insulin delivery system designed with a tubeless, waterproof, Bluetooth-enabled pod capable of holding up to 200 units of U-100 insulin and a touch-screen personal diabetes manager to control the pod.
“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,” president & CEO Shacey Petrovic said in a news 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.”
Last month, Insulet touted the full market launch of the Omnipod Display and Omnipod View apps in the iOS app store to go along with the Omnipod device. Earlier this month, the company priced a private placement of $700 million in convertible senior notes due 2026, with the expectation of bringing in $684.3 million in net proceeds, or $782 million if initial purchasers exercise the additional option in full.
Shares of PODD were up +2% at $158.96 per share in early-morning trading today.
