The FDA has expanded the indication for Fiasp (insulin aspart injection; Novo Nordisk) 100 Units/mL to include use in insulin infusion pumps to improve glycemic control in adults with type 1 or type 2 ...

The expanded approval was based on data from the phase 3 PRONTO-PUMP-2 trial which evaluated Lyumjev vs Humalog for use in insulin pump therapy in 432 adults with type 1 diabetes. The Food and Drug ...

Please provide your email address to receive an email when new articles are posted on . The FDA expanded the indication for insulin aspart injection 100 U/mL to include use in insulin infusion pumps ...

The Food & Drug Administration made its first moves toward stricter regulation of infusion pumps, issuing proposed new guidelines advising manufacturers of the devices that they’ll likely have to run ...

The thin plastic tubing of infusion sets that connect insulin pumps to the body typically need to be changed every two or three days—but a new version in the U.S. more than doubles that timespan. The ...

DUBLIN--(BUSINESS WIRE)--The "Global Infusion Pumps Market (2023 Edition): Analysis By Product Type (Volumetric, Ambulatory, Insulin, PCA, Syringe Pumps, Others), By Indication, End Use, By Region, By ...

Unomedical, which supplies diabetes tech firms including Medtronic, Tandem Diabetes Care and Beta Bionics, received more than 5,000 complaints about leaking infusion sets between 2023 and 2025.

Pump vs control sites had greater vessel density, fibrosis, fibrinogen, and inflammation including eosinophils, insulin-like-growth factor-1 (IGF-1), and transforming growth factor (TGF) β-3, as well ...

addition, the system has multiple safeguards to protect its integrity and prevent unauthorized action. If you are concerned about unauthorized access for any reason, the pump’s radio frequency feature ...

When Polly Varnado's 9-year-old daughter was diagnosed with Type 1 diabetes, it didn't take long for the family to hear about insulin pumps. In September 2012, the girl picked out a purple one — her ...

Skin reactions at insulin pump infusion sites are common among people with type 1 diabetes who use the devices and can lead to delivery failure, new research suggests. Insulin pump use is increasingly ...