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Glucose Monitoring, Insulin Delivery, Topics

Medtronic Receives FDA Approval for Simplera + MiniMed 780G

Here is a brief preview of this blast: Medtronic announced FDA approval of the supplemental PMA for Medtronic’s Simplera Sync CGM sensor for use with the MiniMed 780G system. Recall, the standalone Simplera CGM was approved by FDA in August 2024 (previous FENIX insight). According to the press release, a limited US launch of the Simplera Sync sensor will begin in Fall 2025. Below, FENIX provides brief insight into the approval.

About The Author

Matthew Maryniak

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President of Fenix Group International
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.