WASHINGTON (dpa-AFX) - Medtronic (MDT), a medical device company, on Monday announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its MiniMed Go app. This clearance allows the company to launch the MiniMed Go Smart Multiple Daily Injection (MDI) system.
The MiniMed Go system integrates Medtronic's InPen smart insulin pen with the Instinct continuous glucose sensor developed by Abbott (ABT), all connected through the MiniMed Go mobile app. This system is designed to provide real-time, personalized insights and actionable guidance to individuals managing diabetes with insulin injections.
Key features of the MiniMed Go system include missed dose alerts to help reduce glucose spikes, a built-in dose calculator, action-oriented guidance when doses are missed or miscalculated, and CareLink software reporting to support collaboration with healthcare providers. The system is cleared for individuals aged seven years and older with insulin-requiring type 1 or type 2 diabetes, as well as for children aged two to six under adult supervision.
Medtronic noted that the compatibility of its Simplera sensor with the MiniMed Go app remains under FDA review.
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