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Insulet Announces CE Mark Approval for Omnipod® 5 Automated Insulin Delivery System
ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its
About this update from Insulet Corporation
[{"type":"text","content":" ACTON, Mass.--(BUSINESS WIRE)--\nInsulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received CE marking under the European Medical Device Regulation for its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes.\n\n“There is tremendous enthusiasm for Omnipod 5 from the global diabetes community, and we are thrilled to have achieved this latest milestone,” said Jim Hollingshead, President and CEO of Insulet. “With Omnipod 5, customers can enjoy the lifestyle benefits of a tubeless, wearable innovation and achieve positive clinical outcomes while managing their diabetes.”\n\nOmnipod 5 is the first CE marked tubeless hybrid closed loop system (also known as automated insulin delivery) that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System to automatically adjust insulin and help protect against high and low glucose levels 1. The system2 consists of the tubeless Pod enhanced with SmartAdjustTM technology, the Omnipod 5 Controller with its integrated SmartBolus Calculator, and the Dexcom G6 CGM.\n\nEvery five minutes, SmartAdjust technology receives a CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target.\n\n\"Today’s announcement is a significant step forward for people in Europe living with diabetes,” said Kevin Sayer, Chairman, President and CEO of Dexcom. “We’re proud to partner with Insulet, combining our industry-leading Dexcom G6 CGM technology with their tubeless, wearable insulin delivery system, to improve clinical outcomes and reduce the burden of glucose management for people with diabetes.”\n\nNew clinical data demonstrating the safety and effectiveness of Omnipod 5 on recently diagnosed people with type 1 diabetes will be presented at the upcoming European Association for the Study of Diabetes (EASD) meeting in Stockholm, Sweden on Thursday, September 22. To learn more and to register for EASD, visit the conference website.\n\nInsulet expects Omnipod 5 to be available in select countries starting mid-2023. To learn more about Omnipod 5, visit the Omnipod website...