Insulet’s Omnipod® DASH Insulin Management System Receives FDA 510(k) Clearance

  • DASH System Features Sleek, Color Touch-Screen Handheld Personal Diabetes Manager, Bluetooth-Enabled, Waterproof1,
  • Tubeless Pump
  • Suite of User-Friendly Mobile Applications
  • No-Cost Personal Diabetes Manager with Purchase of Pods

BILLERICA, Mass.–(BUSINESS WIRE)–Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced FDA 510(k) clearance of the Omnipod DASHTM Insulin Management System (Omnipod DASH). This clearance lays the foundation for a steady cadence of innovation that furthers Insulet’s mission to empower users to enjoy simplicity, freedom, and healthier lives with their differentiated technology.

Why is this so exciting?  Significant that per the FDA documentation, it took less than 6 months for approval. Submitted on Jan. 8, 2018 and cleared on June 1. Way to be quick and efficient, FDA! (Thanks Mike Hoskins of DiabetesMine). The Dash is the “skeleton structure” for the Horizon, Insulet’s closed loop system, due out in late 2019.  And you can be sure that Tandem closed loop will not be far behind!

From Insulet’s FAQs:

Can I be part of the limited market release?

We have identified a limited number of endocrinologists who can prescribe the Omnipod DASH System during the limited market release in the United States. Only patients under the care of those endocrinologists and who have coverage for Omnipod DASH System may participate in the Omnipod DASH AHEAD Program.

At this time, each endocrinologist will use their clinical judgment to determine for whom they will prescribe the Omnipod DASH System.  There will be a restricted number of patients per practice involved in the program.  

Our limited market release in the U.S. will last approximately 6 months giving us the opportunity to secure access, build inventory and ensure a successful launch for the diabetes community. We anticipate launching the Omnipod DASH System in early 2019. Please refer to our website myomnipod.com for the latest updates on availability. 

Can I be put on a waiting list or priority list for the Omnipod DASH System?

At this time, there is no prioritization or waiting list. The Omnipod DASH System will be available once we move into a full market release in early 2019. For any further questions, please contact Customer Care at 800-591-3455.

 

Read more:  FAQs: Questions About The System

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