Insulet gets FDA clearance for Omnipod GO insulin delivery device

2023-04-26

上市批准

The FDA clearance for the basal-only insulin pod is for people who would usually take injections of long-acting insulin on a daily basis The Omnipod GO basal-only insulin pod from Insulet. (Photo: Business Wire/Insulet Corporation) Insulet said that its insulin delivery device Omnipod GO has secured the US Food and Drug Administration (FDA) clearance for its use by people with type 2 diabetes aged 18 or more. The FDA clearance for the basal-only insulin pod is for people who would usually take injections of long-acting insulin on a daily basis, said the Massachusetts-based medical device company. According to Insulet, Omnipod Go is a standalone insulin delivery wearable system that delivers a fixed rate of continuous, rapid-acting insulin for a period of 72 hours. It is the latest addition to the company’s Omnipod brand of products and it is equipped with a waterproof and tubeless pod. The pod of the insulin delivery device is available with seven different pre-programmed daily rates, which range between 10 and 40 units a day. Omnipod Go can be operated without the need for a handheld device for controlling the pod. It has been cleared for use with NovoLog, Humalog, Fiasp, Lyumjev, and Admelog, which are all U-100 insulins. Insulet stated that Omnipod Go was developed to help people suffering from type 2 diabetes in the early stages of their treatment by introducing them to pod therapy to deliver insulin, instead of daily injections. If a patient is insulin-dependent, that is, they need both bolus and basal insulin, then the switch to a different Omnipod product will be smooth, claimed the company. The medical device company intends to commercialise the Omnipod GO insulin delivery device in the US in 2024. Insulet president and CEO Jim Hollingshead said: “Omnipod GO was designed to serve the more than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes. “Our goal is to help people with type 2 diabetes successfully shift to insulin therapy with a product that fundamentally changes how they feel about diabetes management. We’re excited to bring this new solution to market and deliver on our mission to simplify life for people with diabetes.”

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