Medtronic nets approval for diabetes management system in U.S.

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The FDA has approved Medtronic’s MiniMed Paradigm Real-Time Revel system, the diabetes management system (insulin pump therapy, continuous glucose monitoring (CGM) and diabetes therapy management software).

The system incorporates new CGM features including predictive alerts that can give warning to people with diabetes so they can take action to prevent dangerous high or low glucose events, according to the Minneapolis-based company.

Several new CGM features, including predictive and rate of change alerts, provide earlier warnings of potential glycemic excursions to help patients stay in their target range, Medtronic said. The updated insulin pump allows patients to tailor insulin delivery to meet their personal needs. Patients who are sensitive to insulin, such as children with diabetes, can have the opportunity to deliver insulin in smaller increments (0.025 units per hour).