OmniPod users have been in limbo for over a year after Abbott changed to the new “butterfly” test strips because they weren’t FDA approved for use in the Insulet OmniPod insulin pump PDM.
Some have been using the new strips because they weren’t able to get the older style strips any more. Some were frantically searching for the old style afraid that they were not accurate or not safe. Some were using the new strips in an alternate, separate meter. And some were using the new ones just plain because they liked them better and they seemed to be working just fine.
This morning FDA approval of the Abbott FreeStyle “butterfly” strips was announced.
Here are portions of the announcement:
The FDA granted 510(k) clearance to Abbott’s Freestyle glucose test strip for use with Insulet’s OmniPod insulin management system.
“The FDA has notified the company that the new Abbott Freestyle test strip has been cleared for use with the OmniPod,” Insulet confirmed in an email to MassDevice. “The companies are in the midst of updating the product label and will be communicating with customers once that has been completed, hopefully next week.”
It’s good news for Bedford, Mass.-based Insulet, as Abbott’s Freestyle is one of the most popular test strips on the market.
Insulet is awaiting word from the federal watchdog agency on its 510(k) application for the next-generation OmniPod it says will help reduce production costs by more than a third.
The latest version of the system is ⅓ smaller, 25 percent lighter and “expected to reduce our cost of production by about a third, driving significant gross margin improvement,” CEO Duane DeSisto said in May 2011. “We are confident that the easy-to-use design of our tubeless insulin pump will raise the bar for the industry again and improve our competitive position in the marketplace.”
Images from the FreeStyle website.
Thanks to Lorraine for the tip. I saw her mention it before I saw it on MassDevice’s feed this morning.
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