Bedford-based Insulet Corp. (Nasdaq: PODD) has received 510(k) clearance from the U.S. Food and Drug Administration for a new insulin pump that’s smaller and lighter than its current product.

The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, which was introduced in 2005, according to the company. Insulet expects the first shipments of the new device to come to the U.S. around March, and plans to convert current users of the device to the new one.

“The OmniPod revolutionized insulin delivery with its tubeless and wireless design when it was introduced in 2005 and today, the next-generation OmniPod raises the bar for insulin pump therapy again,” said Duane DeSisto, president and CEO of Insulet in a statement. “We are thrilled to have received FDA approval and it is my hope that our new OmniPod insulin pump will continue to make living with diabetes easier for our customers across the United States.”

Information for customers will be posted on the company’s website http://www.MyOmniPod.com/NewOmniPod as to when and where the new system will be available, and current users will also be notified when the conversion process starts, the company said.

Founded in 2000, the company has been struggling to maintain profitability. In August 2011, DeSisto told Mass High Tech that the “first milestone is to get to cash flow even and then cash flow positive by the fourth quarter…. By the end of 2012, the goal is to be profitable.” As of Nov. 8, however, the company said its expecting a 2012 operating loss of between $35 million and $38 million, with revenues in the range of $210-$215 million

Boston Business Journal

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