Asante’s New Insulin Pump Receives FDA 510(k) Clearance

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The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Asante Solutions’ Pearl Insulin Pump. The pump has also received the CE Mark, a European proof of conformity that certifies the product meets EU safety, health and environmental requirements.
 
According to the company’s press release, the Pearl insulin pump is the first fully-programmable insulin pump cleared under the FDA’s new more comprehensive and stringent infusion pump guidelines. The pump features a unique modular product configuration that allows significantly lower pump therapy initiation costs through pay-as-you-pump pricing. It is the only insulin pump using glass pre-filled 300 unit insulin cartridges for use in pumps for up to seven days.
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Melissa Willey-Crystle
Melissa Willey-Crystle
9 years ago

THIS IS SHARP LOOKING!  i WANT TO GET ONE AS A TRIAL USE AND SEE HOW IT WORKS….

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