FOR IMMEDIATE RELEASE
"All-in-One" Blood Glucose Monitor and Insulin Pump Gains FDA Clearance
St. Paul, MN, June 1, 2004 - Smiths Medical MD, Inc., makers of the Deltec Cozmo® Insulin Pump, announces that they have received 510(k) clearance for the CoZmonitorTM blood glucose module. The CoZmonitorTM blood glucose module is attached to the back of the Deltec Cozmo® insulin pump to create an "all-in-one" insulin pump and blood glucose monitoring system.1 The Deltec Cozmo® insulin pump keypad and screen are used for all blood glucose testing functions and results.
Smiths Medical MD, Inc, partnered with Abbott Diabetes Care to create the CoZmonitorTM blood glucose module, which utilizes FreeStyle FlashTM technology and readily available FreeStyle® test strips. "It was very important for us to partner with a company like Abbott Diabetes Care so we could utilize their proven blood glucose monitoring and test strip technology rather than creating something completely new," said Rod Kellogg, Vice President and General Manager of the Diabetes Division of Smiths Medical MD, Inc.
To support FDA 510(k) clearance, a CoZmonitorTM blood glucose module usability study was conducted with 57 children and adults. All 57 participants were able to successfully use the CoZmonitorTM blood glucose module without any additional training. "The CoZmonitorTM blood glucose module is a major advancement in making diabetes management easier," said Dr. Howard Wolpert, Director, Insulin Pump Program, Joslin Diabetes Center. "Blood glucose monitoring is essential for good diabetes management. By attaching the CoZmonitorTM blood glucose module to the back of the Deltec Cozmo® insulin pump, patients will never have to worry about where their blood glucose monitor is."
The CoZmonitorTM blood glucose module can only be used with the Deltec Cozmo® insulin pump. Smiths Medical anticipates filling orders for the CoZmonitorTM blood glucose module beginning in August 2004.
To place an order or for more information, visit www.cozmore.com or call 1-800-826-9703.
Smiths Medical MD, Inc., formerly Deltec, Inc., is a world leader in the design, manufacture, and distribution of medical devices used in infusion therapy, including ambulatory infusion pumps, large volume infusion pumps, implantable access systems, dialysis and infusion catheters, needles, and insulin delivery systems. Headquartered in St. Paul, Minn., Smiths Medical MD (Medication Delivery) is part of Smiths Group plc, London, and is committed to developing the highest quality, most reliable products to provide innovative, convenient, and cost-effective drug delivery worldwide.
Contact: Terri Servais
Phone: (651) 628-7248
E-mail: [email protected]
1The CoZmonitorTM blood glucose monitor will only function when attached to the Deltec Cozmo® insulin pump and can not be used as a stand-alone device or with any other insulin pump.
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