Medtronic Announces FDA Clearance Of New OneTouch(R) Ultralink(TM) Blood Glucose Meter

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices
Article Date: 29 Apr 2008 - 4:00 PDT

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Medtronic, Inc. (NYSE: MDT) announced that the FDA has cleared the OneTouch® UltraLink™ Meter as the new wireless meter exclusively certified by Medtronic to wirelessly communicate with Medtronic diabetes management products in the United States. This new 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.

The OneTouch® UltraLink™ Meter is the newest addition to the long-trusted OneTouch® Meter Family - the number one prescribed meter brand - and uses OneTouch® Ultra® Test Strips, the number-one selling test strip in the United States. Data transmitted from the OneTouch® UltraLink™ Meter can be viewed via Medtronic's proprietary CareLink™ Therapy Management Software, the only software that integrates meter, logbook, insulin pump and real-time continuous glucose monitoring information to help patients and physicians more easily assess and manage diabetes.

"At Medtronic, we are committed to leading the technology revolution in diabetes management and delivering best-in-class solutions to patients," said Chris O'Connell, president of the Diabetes business at Medtronic. "Together with LifeScan, we will continue to advance the opportunities for people with diabetes to proactively and conveniently manage their diabetes while maximizing their quality of life."

Medtronic is actively working to provide the OneTouch® UltraLink™ Meter to all of its customers as soon as possible, and is taking a staged product launch approach. 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 new meters at no charge to eligible U.S. customers, and plans to complete this process later this year.

Medtronic currently markets the MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System - the world's only insulin pump with REAL-Time continuous glucose monitoring (CGM). The MiniMed Paradigm REAL-Time System has all of the benefits of CGM plus the added value of precise insulin delivery through the use of insulin pump therapy.

About The Diabetes Business at Medtronic

The Diabetes business at Medtronic is the world leader in advanced diabetes management solutions, including integrated diabetes management systems, insulin pump therapy, continuous glucose monitoring systems and therapy management software.

The Diabetes Business at Medtronic

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic, Inc.