Medtronic Reports 510(k) Clearance of MiniMed Go System for Diabetes Management
Shots:
- FDA has granted 510(k) clearance to MiniMed Go app, powering the MiniMed Go Smart MDI system that integrates the InPen smart insulin pen with Abbott’s Instinct glucose sensor for diabetes management; commercial launch expected in spring of 2026
- The MiniMed Go system is cleared for people with insulin-requiring type 1 & type 2 diabetes aged ≥7yrs, & for children aged 2–6yrs. Compatibility with the Simplera sensor is currently under FDA review
- Real-world data from Medtronic’s prior Smart MDI system showed Time in Range improved from 55.7% to 67.2% when users responded to >75% of Missed Dose alerts within an hour, & to 71.5% when Correct High Glucose alerts were addressed with a bolus within an hour
Ref: Medtronic  | Image: Medtronic | Press Release
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