Insulet has gained the US Food and Drug Administration's (FDA) 510(k) approval for its new version of tubeless insulin pump.
The new easy-to-use OmniPod insulin management system features the same 200-unit insulin reservoir capacity, but is more than one-third smaller and one-quarter lighter than the original insulin pump.
The new system also features a series of enhancements in the Personal Diabetes Manager (PDM), which wirelessly programs the automatic waterproof Pod worn on many parts of the body to hold and deliver insulin.
In addition, the PDM has a built-in blood glucose meter for calculating suggested doses.
University of California at San Diego medicine clinical professor and Taking Control of Your Diabetes founder Steve Edelman said, "When technology can make diabetes management easier for my patients, they have better clinical outcomes."
Insulet president and chief executive officer Duane DeSisto said preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of manufacturing production.
"We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the U.S. to occur in late Q1 2013," DeSisto added.
