The US Food and Drug Administration (FDA) has granted 510(k) clearance to Insulet’s new version of its tubeless insulin pump, designed for use in patients with diabetes.
Featuring the same 200-unit insulin reservoir capacity, the new easy-to-use OmniPod insulin management system 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 clinical professor of medicine and Taking Control of Your Diabetes founder Dr Steve Edelman said; "When technology can make diabetes management easier for my patients, they have better clinical outcomes."
Insulet president and CEO Duane DeSisto said the OmniPod with its tubeless and wireless design raises the bar for insulin pump therapy again.
"Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production," DeSisto said.
"We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the US to occur in late Q1 2013.
"Like the system itself, converting our current OmniPod users to the new system has been designed to be extremely easy as to ensure a seamless transition."