logo
Share SHARE
FONT-SIZE Plus   Neg

Insulet Receives 510(k) Clearance For OmniPod Insulin Management System

Insulet Corp.(PODD) announced Friday that it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for the next-generation OmniPod Insulin Management System.

The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features.

In addition to the smaller, lighter Pod, the new OmniPod System includes an updated Personal Diabetes Manager or PDM that also features a series of enhancements.

"Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production. We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the U.S. to occur in late Q1 2013. Like the System itself, converting our current OmniPod users to the new system has been designed to be extremely easy as to ensure a seamless transition," said Duane DeSisto, President and Chief Executive Officer of Insulet.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
The Coca-Cola Company (KO) reported a profit for the first-quarter of 2017 that declined 20 percent from the prior year. Net revenues declined 11%, reflecting unfavorable impacts from structural changes of 10% and foreign currency of 1%. The company remains on track to deliver its underlying revenue and profit targets for the full year. Eli Lilly and Co. (LLY) reported a loss for the first quarter of 2017 compared to profit in the prior year, primarily hurt by lower operating income, partially offset by higher other income. But, quarterly revenue increased 7 percent, driven by 9 percent pharmaceutical volume growth from Trulicity, Taltz and other new products. Capricor Therapeutics, Inc., a clinical-stage biotechnology company for cardiac and other medical conditions, announced Tuesday positive six-month results from the randomized phase I/II HOPE clinical trial in Duchenne muscular dystrophy or DMD. The HOPE clinical trial was designed to evaluate the safety and exploratory efficacy of CAP-1002.
comments powered by Disqus
Follow RTT