Asante Solutions said the FDA has granted 510(k) clearance for the company’s Pearl Insulin Pump. The Pearl has also received the CE Mark, a European proof of conformity that certifies the product meets EU safety, health and environmental requirements.
The Pearl Insulin Pump’s 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.
“The Pearl Insulin Pump’s utilization of a pre-filled insulin cartridge is an evolutionary step forward for those on intensive insulin therapy,” said James Chamberlain, MD, medical director for Diabetes Services at St. Mark’s Hospital and St. Mark’s Diabetes Center. “The fact that the Pearl minimizes all the ‘plumbing’ issues associated with reservoir filling in other insulin pumps makes it an attractive choice as a starter pump for those initiating insulin pump therapy as well as for those seeking greater ease of use. The Pearl is designed to reduce steps, add convenience, and save time.”