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.