www.fdanews.com/articles/193240-insulet-earns-additional-fda-clearance-for-insulin-management-systems
Insulet Earns Additional FDA Clearance for Insulin Management Systems
October 28, 2019
The FDA granted Insulet 510(k) clearance for the use of Novo Nordisk’s fast-acting insulin with its Omnipod and Omnipod DASH insulin management systems.
Fiasp (fast-acting insulin aspart) enters the patient’s bloodstream twice as fast as the company’s NovoLog product, improving glycemic control. The drug also has no pre-meal dosing recommendation.
“Omnipod can now be used with the full spectrum of insulin, from generic to branded to ultra-fast-acting, and we are thrilled to deliver this additional flexibility for people to use their insulin of choice with the Omnipod system,” said Insulet’s medical director, Trang Ly.