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

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.

ASweetLife Team

FDA: New Medtronic 770G Insulin Pump Approved for Ages 2+ The FDA has approved Medtronic's 770G insulin pump, the newest hybrid closed loop system, for use in patients as young as 2 years old. Parents of young children with Type…
FDA Approves Tandem’s t:slim X2 Insulin Pump with… The U.S. FDA has announced clearance of an expanded pediatric indication for the Tandem’s t:slim X2™ insulin pump with Control-IQ™ technology to children age 6 and older. The product was previously approved for ages 14…
FDA approves Lyumjev, Lilly’s New Rapid-Acting Insulin The U.S. FDA has approved Lyumjev, Lilly’s new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Lyumjev (insulin lispro-aabc injection, 100 units/mL…
New Insulin Affordability Survey: 40% Struggle to Afford… A new survey shows that 44% of Americans that use insulin to treat their diabetes have struggled to afford their insulin in the last year. The survey is also the…
FDA Green Lights Trials of New Type 1 Diabetes Stem Cell… The United States Food and Drug Administration (FDA) has given the green light for experimental trials of a truly new therapy for Type 1 diabetes. The new therapy, named VX-880,…