FDA clears Abbott's Freestyle for use with Insulet's OmniPod

January 6, 2012 by MassDevice staff

The FDA granted 510(k) clearance to Abbott's Freestyle glucose test strip for use with Insulet's OmniPod insulin management system.

Insulet

The FDA granted 510(k) clearance to Abbott's (NYSE:ABT) Freestyle glucose test strip for use with Insulet's (NSDQ:PODD) OmniPod insulin pump.

"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.

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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."

Last November, Insulet reported wider third-quarter losses than expected and lowered its full-year sales guidance, despite logging a 75.2 percent addition to the top line.

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