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Devices Drug Delivery Endocrinology FDA

 News Release - November 20, 2006

FDA Clearance Received for CozMore(R) Insulin Technology System Updates

SAINT PAUL, Minn.--(HSMN NewsFeed)--Smiths Medical MD, Inc., part of the global engineering business Smiths Group and makers of the CozMoreŽ insulin technology system, announces that they have received Food and Drug Administration (FDA) 510(k) clearance for new pump software features.

"We're proud to offer new features and programming that are intended to help our customers better control their diabetes. These advances further support our mission to keep the CozMoreŽ system on the leading edge of insulin pump technology," said Jim Stitt, president of Smiths Medical MD, Inc.

The new features expand the personalization capabilities of the CozMoreŽ system. The CozMoreŽ system includes the Deltec CozmoŽ insulin pump, the CoZmanagerŽ PC communications software and the CoZmonitorŽ blood glucose module.

The following are just some of the new features available only through the CozMoreŽ system:
  • Enhanced Meal MakerŽ carbohydrate calculating feature - A food database that lists carbohydrate amounts that make it easier for customers to track their carbohydrate intake.
  • Weekly Schedule - Lets customers program several settings to occur automatically by the time and day of the week so they don't have to change settings every day.
  • Disconnect feature - A feature that calculates the insulin that would be missed when customers remove the Deltec CozmoŽ pump for up to two hours and lets them take part of that missed insulin before and after they disconnect.
  • QuickStart(TM) feature - In one convenient pump menu, customers have a one-stop place to program the basics of the Deltec CozmoŽ insulin pump, which can get their pump therapy started quickly and easily.
  • Hypo Manager(TM) feature - A feature that recommends the number of carbohydrates a customer should eat to correct a low blood sugar test result, which gets the customer back to a healthier condition.
"The majority of these advancements came from suggestions made by our valued customers and the healthcare professionals who recommend and prescribe the CozMoreŽ system," Stitt said.

The updates also include a change in Deltec CozmoŽ insulin pump colors. The newest Deltec CozmoŽ pumps will be available in Tropical Green, Pacific Blue, and Volcano Black. The current colors will be retired.

The updated software and enhancements will be sold only in the United States and in China.

For more information on the CozMoreŽ insulin technology system, please visit www.cozmore.com or call 800-826-9703.

Diabetes and Insulin Pumps

Insulin is a hormone produced by the pancreas that converts sugar (glucose) into energy that is needed for daily life. In Type 1 diabetes, the body does not produce insulin. In Type 2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin. Without insulin, blood sugars rise uncontrollably, endangering the health and life of the person with diabetes. An insulin pump, like the Deltec CozmoŽ pump, provides a steady insulin supply (called basal insulin) throughout the day and night as well as larger doses (or boluses) of insulin to control the sugar, starch, and carbohydrates a person eats. Insulin is delivered through a pump the size of a cell phone and attached to the body with tubing. Although blood glucose tests are still needed, an insulin pump eliminates the need for multiple daily insulin injections for people with diabetes.

Smiths Group

Smiths is a global engineering business, listed on the London Stock Exchange. Smiths Group focuses on high performance applications, building and sustaining market-leading businesses in growth sectors. It reaches deep into global markets taking its manufacturing closer to its customers. Smiths Group has four divisions: Aerospace, Detection, Medical and Specialty. It employs 32,000 people and has over 250 major facilities in 50 countries. For more information visit www.smiths-group.com

Smiths Medical

Smiths Medical is a supplier of specialist medical devices to global markets. Smiths Medical comprises three product groupings: Safety Devices, Critical Care and Medication Delivery (MD), and Patient Monitoring (MDPM). Smiths Medical customers include hospitals and other healthcare providers worldwide. Smiths Medical employs nearly 7,500 people. For further information visit www.smiths-medical.com


Source: Smiths Medical MD

Issuer of this News Release is solely responsible for its content.
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