FDA clears Insulet’s Omnipod Dash insulin management system

Insulet (NSDQ:PODD) said today that the FDA granted 510(k) clearance to its Omnipod Dash insulin management system.

The system wirelessly connects the company’s Personal Diabetes Manager with its tubeless, waterproof insulin pump. The PDM calculates how much insulin should be administered using blood glucose readings from the Contour Next One blood glucose meter. Altogether, the system connects via Bluetooth to the Omnipod Display and Omnipod View apps, which provide users and caregivers with access to their insulin therapy data.

“Omnipod Dash was inspired by Podders and embodies what users on multiple daily injections have been asking for in a diabetes management system,” chairman & CEO Patrick Sullivan said in prepared remarks. “Our number one priority is to continue to minimize the daily strain on those impacted by diabetes and we are confident this system, and eliminating the system’s upfront cost, do just that.”

Insulet plans to release the Omnipod Dash system in early 2019 in the U.S.

“I’m thrilled with the new Omnipod Dash system,” said Tessa Mellinger, a Type I diabetic who took part in the Dash user testing process. “The PDM display is easy to read, the steps to managing basal rates are user friendly, and the food library is really helpful. The fact that it looks like a smartphone makes it cool to carry and may help eliminate those awkward questions from strangers.”

In May, Insulet topped estimates on Wall Street yesterday with its first-quarter results, topping analysts’ sales expectations by $1.9 million.

The Billerica, Mass.-based company reeled in its losses, posting a net loss of -$6.6 million, or -11¢ per share, on sales of $123.6 million for the 3 months ended March 31, for bottom-line growth of 34.2% on sales growth of 21.5% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were -11¢, ahead of consensus on The Street, where analysts were looking for sales of $121.7 million.

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