FDA Clears Medtronic and LifeScan to Market Integrated Wireless Diabetes Management System

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The FDA has cleared the OneTouch UltraLink wireless meter as the only meter certified by Medtronic to wirelessly communicate with its diabetes management products in the United States. The meter uses Medtronic-certified wireless technology to transmit glucose readings directly to MiniMed Paradigm insulin pumps and the Guardian® REAL-Time continuous glucose monitoring system. This makes bolus dosing more accurate and easier for patients compared to the manual entry of blood glucose readings.

Data transmitted from the OneTouch UltraLink meter can be viewed via Medtronic’s proprietary CareLink therapy management software, which integrates meter, logbook, insulin pump and real-time continuous glucose monitoring information to help patients and doctors more easily assess and manage diabetes.

Medtronic is working to provide the OneTouch UltraLink meter to all of its customers, current and new, as soon as possible. All new U.S. customers who order a MiniMed Paradigm REAL-Time System or Guardian REAL-Time System will receive the OneTouch UltraLink meter at no charge. The company will immediately start shipping the meters at no charge to eligible U.S. customers, and plans to complete this process later this year.

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